Label

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

ELAHERE safely and effectively. See full prescribing information for

ELAHERE.

ELAHERE

(mirvetuximab soravtansine-gynx) injection, for

intravenous use

Initial U.S. Approval: 2022

WARNING: OCULAR TOXICITY

See full prescribing information for complete boxed warning.

• ELAHERE can cause severe ocular toxicities, including visual

impairment, keratopathy, dry eye, photophobia, eye pain, and

uveitis. (5.1, 6.1)

• Conduct an ophthalmic exam including visual acuity and slit

lamp exam prior to initiation of ELAHERE, every other cycle

for the first 8 cycles, and as clinically indicated. (2.3)

• Administer prophylactic artificial tears and ophthalmic topical

steroids. (2.3, 5.1)

• Withhold ELAHERE for ocular toxicities until improvement

and resume at the same or reduced dose. (2.4, 5.1)

• Discontinue ELAHERE for Grade 4 ocular toxicities. (2.4, 5.1)

-----------------------------INDICATIONS AND USAGE--------------------------

ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule

inhibitor conjugate indicated for the treatment of adult patients with FRα

positive, platinum-resistant epithelial ovarian, fallopian tube, or primary

peritoneal cancer, who have received one to three prior systemic treatment

regimens. Select patients for therapy based on an FDA-approved test. (1, 2.1)

This indication is approved under accelerated approval based on tumor

response rate and durability of response. Continued approval for this

indication may be contingent upon verification and description of clinical

benefit in a confirmatory trial. (1, 14)

------------------------DOSAGE AND ADMINISTRATION----------------------

• Administer ELAHERE as an intravenous infusion only after dilution in 5%

Dextrose Injection, USP. ELAHERE is incompatible with normal saline.

(2.5)

• The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body

weight administered as an intravenous infusion every 3 weeks until disease

progression or unacceptable toxicity. (2.2)

• Premedicate with a corticosteroid, antihistamine, and antipyretic. (2.3)

• Premedicate with an antiemetic, ophthalmic topical steroids, and

lubricating eye drops. (2.3, 5.1)

• See full Prescribing Information for preparation and administration

instructions and dose modifications for adverse reactions. (2)

---------------------DOSAGE FORMS AND STRENGTHS----------------------

• Injection: 100 mg/20 mL (5 mg/mL) in a single-dose vial. (3)

-------------------------------CONTRAINDICATIONS------------------------------

• None. (4)

------------------------WARNINGS AND PRECAUTIONS-----------------------

• Pneumonitis: Withhold ELAHERE for persistent or recurrent Grade 2

pneumonitis and consider dose reduction. Permanently discontinue

ELAHERE for Grade 3 or 4 pneumonitis. (2.4, 5.2)

• Peripheral Neuropathy: Monitor patients for new or worsening peripheral

neuropathy. Withhold dosage, dose reduce, or permanently discontinue

ELAHERE based on the severity of peripheral neuropathy. (2.4, 5.3)

• Embryo-Fetal Toxicity: ELAHERE can cause fetal harm. Advise of the

potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3)

-------------------------------ADVERSE REACTIONS------------------------------

The most common (≥20 %) adverse reactions, including laboratory

abnormalities, were vision impairment, fatigue, increased aspartate

aminotransferase, nausea, increased alanine aminotransferase, keratopathy,

abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea,

decreased albumin, constipation, increased alkaline phosphatase, dry eye,

decreased magnesium, decreased leukocytes, decreased neutrophils, and

decreased hemoglobin. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact ImmunoGen

at 1-833-486-4646 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

----------------------------DRUG INTERACTIONS---------------------------------

Strong CYP3A4 Inhibitors: Closely monitor for ELAHERE adverse reactions.

(7.1)

--------------------------USE IN SPECIFIC POPULATIONS---------------------

• Lactation: Advise not to breastfeed. (8.2)

• Moderate or severe hepatic impairment: Avoid use. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and Medication

Guide.

Revised: 11/2022

FULL PRESCRIBING INFORMATION: CONTENTS*

BOXED WARNING

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

2.2 Recommended Dosage

2.3 Premedication and Prophylactic Regimen

2.4 Dosage Modifications

2.5 Instructions for Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Ocular Disorders

5.2 Pneumonitis

5.3 Peripheral Neuropathy

5.4 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on ELAHERE

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.6 Immunogenicity

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

* Sections or subsections omitted from the full prescribing

information are not listed.

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FULL PRESCRIBING INFORMATION

WARNING: OCULAR TOXICITY

• ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry

eye, photophobia, eye pain, and uveitis [see Warnings and Precautions (5.1) and Adverse

Reactions (6.1)].

• Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of

ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated [see Dosage

and Administration (2.3)].

• Administer prophylactic artificial tears and ophthalmic topical steroids [see Dosage and

Administration (2.3) and Warnings and Precautions (5.1)].

• Withhold ELAHERE for ocular toxicities until improvement and resume at the same or

reduced dose [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].

• Discontinue ELAHERE for Grade 4 ocular toxicities [see Dosage and Administration (2.4)

and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

ELAHERE

™

is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-

resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior

systemic treatment regimens. Select patients for therapy based on an FDA-approved test [see Dosage and

Administration (2.1)].

This indication is approved under accelerated approval based on tumor response rate and durability of response

[see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and

description of clinical benefit in a confirmatory trial.

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal

cancer with ELAHERE based on the presence of FRα tumor expression [see Indications & Usage (1) and

Clinical Studies (14)] using an FDA-approved test.

Information on FDA-approved tests for the measurement of FRα tumor expression is available at

http://www.fda.gov/CompanionDiagnostics.

2.2 Recommended Dosage

The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every

3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity [see

Dosage and Administration (2.5)].

The total dose of ELAHERE is calculated based on each patient’s AIBW using the following formula:

AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] – IBW)

Female IBW (kg) = 0.9*height(cm) – 92

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2.3 Premedication and Required Eye Care

Premedication

Administer the premedications in Table 1 prior to each infusion of ELAHERE to reduce the incidence and

severity of infusion related reactions (IRRs), nausea, and vomiting.

Table 1: Premedication Prior to Each ELAHERE Infusion

Premedication Route of Administration Examples (or equivalent)

Administration Time

Prior to ELAHERE

Infusion

Corticosteroid intravenous dexamethasone 10 mg

At least 30 minutes prior

Antihistamine oral or intravenous

diphenhydramine 25 mg to

50 mg

Antipyretic oral or intravenous

acetaminophen 325 mg to

650 mg

Antiemetic oral or intravenous

5-HT

serotonin receptor

antagonist or appropriate

alternatives

Before each dose and

thereafter as needed

Consider additional premedications including corticosteroids the day prior to ELAHERE administration for

patients who experienced IRRs.

Ophthalmic Exams and Premedication

Ophthalmic exam: Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of

ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.

Ophthalmic Topical Steroids: The use of ophthalmic topical steroids is recommended. The initial prescription

and renewals of any corticosteroid medication should be made only after examination with a slit lamp.

Administer one drop of ophthalmic topical steroids in each eye 6 times daily starting the day prior to each

infusion until day 4; then administer one drop in each eye 4 times daily for days 5-8 of each cycle of ELAHERE

[see Warnings and Precautions (5.1)].

Lubricating Eye Drops: The use of lubricating eye drops at least four times daily and as needed is recommended

during treatment with ELAHERE. Instruct patients to use lubricating eye drops and advise to wait at least 10

minutes after ophthalmic topical steroid administration before instilling lubricating eye drops [see Warnings

and Precautions (5.1)].

2.4 Dosage Modifications

Table 2 provides dose reductions and modifications for adverse reactions. Adjust the schedule of administration

to maintain a 3-week interval between doses.

Table 2: Dosage Reduction Schedule

ELAHERE Dose Levels

Starting Dose 6 mg/kg AIBW

First Dose Reduction 5 mg/kg AIBW

Second Dose Reduction 4 mg/kg AIBW

* Permanently discontinue in patients who cannot tolerate 4 mg/kg AIBW.

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Table 3: Dosage Modifications for Adverse Reactions

Adverse Reaction

Severity of Adverse

Reaction

Dosage Modification

Keratitis/Keratopathy

[see Warnings and

Precautions (5.1) and

Adverse Reactions (6.1)]

Nonconfluent superficial

keratitis

Monitor.

Confluent superficial

keratitis, a cornea

epithelial defect, or 3-line

or more loss in best

corrected visual acuity

Withhold dose until improved or resolved, then maintain

at same dose level or consider dose reduction.

Corneal ulcer or stromal

opacity or best corrected

distance visual acuity

20/200 or worse

Withhold dose until improved or resolved, then reduce by

one dose level.

Corneal perforation Permanently discontinue.

Uveitis

[see Warnings and

Precautions (5.1) and

Adverse Reactions (6.1)]

Grade 1/ Rare cell in

anterior chamber

Monitor.

Grade 2/ 1-2+ Cell or

Flare in anterior chamber

Withhold dose until Grade 1 or less, then maintain dose at

same dose level.

Grade 3/ 3+ Cell or Flare

in anterior chamber

Withhold dose until Grade 1 or less, then reduce dose by

one dose level.

Grade 4/ Hypopyon Permanently discontinue.

Pneumonitis

[see Warnings and

Precautions (5.2) and

Adverse Reactions (6.1)]

Grade 1 Monitor.

Grade 2

Withhold dose until Grade 1 or less, then resume at same

dose level or one lower dose level at the discretion of the

healthcare provider.

Grade 3 or 4 Permanently discontinue.

Peripheral Neuropathy

[see Warnings and

Precautions (5.3) and

Adverse Reactions (6.1)]

Grade 2

Withhold dose until Grade 1 or less, then reduce by one

dose level.

Grade 3 or 4 Permanently discontinue.

Infusion-Related

Reactions/Hypersensitivity

[see Adverse Reactions (6.1)]

Grade 1 Maintain infusion rate.

Grade 2

• Interrupt infusion and administer supportive

treatment.

• After recovery from symptoms, resume the infusion at

50% of the previous rate, and if no further symptoms

appear, increase rate as appropriate until infusion is

completed [see Dosage and Administration (2.5)].

• Administer additional premedication for future cycles

[see Dosage and Administration (2.3)].

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Adverse Reaction

Severity of Adverse

Reaction

Dosage Modification

Grade 3 or 4

• Immediately stop infusion and administer supportive

treatment.

• Advise patient to seek emergency treatment and

immediately notify their healthcare provider if the

infusion-related symptoms recur.

• Permanently discontinue.

Other Adverse Reactions

[see Adverse Reactions (6.1)]

Grade 3

Withhold dose until Grade 1 or less, then resume at one

lower dose level.

Grade 4 Permanently discontinue.

Unless otherwise specified, National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

2.5 Instructions for Preparation and Administration

Preparation

• ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures

• Calculate the dose (mg) (based on the patient’s AIBW), total volume (mL) of solution required, and

the number of vials of ELAHERE needed [see Recommended Dosage (2.2) and Dose Modifications

(2.4)]. More than one vial will be needed for a full dose.

• Remove the vials of ELAHERE from the refrigerator and allow to warm to room temperature.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit. ELAHERE is a clear to slightly opalescent,

colorless solution.

• Gently swirl and inspect each vial prior to withdrawing the calculated dose volume of ELAHERE

for subsequent further dilution. Do not shake the vial.

• Using aseptic technique, withdraw the calculated dose volume of ELAHERE for subsequent further

dilution.

• ELAHERE contains no preservatives and is intended for single-dose only. Discard any unused drug

remaining in the vial.

Dilution

• ELAHERE must be diluted prior to administration with 5% Dextrose Injection, USP to a final

concentration of 1 mg/mL to 2 mg/mL.

• ELAHERE is incompatible with 0.9% Sodium Chloride Injection. ELAHERE must not be mixed

with any other drugs or intravenous fluids.

• Determine the volume of 5% Dextrose Injection, USP required to achieve the final diluted drug

concentration. Either remove excess 5% Dextrose Injection, USP from a prefilled intravenous bag or

add the calculated volume of 5% Dextrose Injection, USP to a sterile empty intravenous bag. Then

add the calculated dose volume of ELAHERE to the intravenous bag.

• Gently mix the diluted drug solution by slowly inverting the bag several times to assure uniform

mixing. Do not shake or agitate.

• If the diluted infusion solution is not used immediately, store solution either at ambient temperature

[(18°C to 25°C (64.4°F to 77°F)] for no more than 8 hours (including infusion time), or under

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refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 12 hours. If refrigerated, allow the

infusion bag to reach room temperature prior to administration. After refrigeration, administer

diluted infusion solutions within 8 hours (including infusion time).

• Do not freeze prepared infusion solution.

Administration

• Inspect the ELAHERE intravenous infusion bag visually for particulate matter and discoloration

prior to administration.

• Administer pre-medications prior to ELAHERE administration [see Premedication and Prophylactic

Regimen (2.3)].

• Administer ELAHERE as an intravenous infusion only, using a 0.2 or 0.22 µm polyethersulfone

(PES) in-line filter. Do not substitute other membrane materials.

• Administer the initial dose as an intravenous infusion at the rate of 1 mg/min. If well tolerated after

30 minutes at 1 mg/min, the infusion rate can be increased to 3 mg/min. If well tolerated after 30

minutes at 3 mg/min, the infusion rate can be increased to 5 mg/min.

• If no infusion-related reactions occur with the previous dose, subsequent infusions should be started

at the maximally tolerated rate and may be increased up to a maximum infusion rate of 5 mg/min, as

tolerated.

• Following the infusion, flush the intravenous line with 5% Dextrose Injection, USP to ensure

delivery of the full dose. Do not use any other intravenous fluids for flushing.

3 DOSAGE FORMS AND STRENGTHS

Injection: 100 mg/20 mL (5 mg/mL) clear to slightly opalescent, colorless solution in a single-dose vial.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal

disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 61% of patients with ovarian cancer treated with ELAHERE. Nine percent

(9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment,

keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%)

experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment

(49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%) [see Adverse

Reactions (6.1)].

The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients

who experienced ocular events, 49% had complete resolution and 39% had partial improvement (defined as a

decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led

to permanent discontinuation of ELAHERE in 0.6% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE

are recommended [see Dosage and Administration (2.3)]. Advise patients to avoid use of contact lenses during

treatment with ELAHERE unless directed by a healthcare provider.

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Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam

prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer

patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and

persistence of ocular adverse reactions. [see Dosage and Administration (2.4)].

5.2 Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients

treated with ELAHERE.

Pneumonitis occurred in 10% of patients treated with ELAHERE, including 0.8% with Grade 3 events, and 1

patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of

pneumonitis and lung metastases. Pneumonitis resulted in ELAHERE dose reduction in 1%, dose interruptions

in 3%, and permanent discontinuation in 3% of patients.

Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough,

dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such

symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who

develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose

reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis [see Dosage and

Administration (2.4)]. Patients who are asymptomatic may continue dosing of ELAHERE with close

monitoring.

5.3 Peripheral Neuropathy

Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical

trials; 2% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions

included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity

(3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and

oral hypoesthesia (0.2%).

The median time to onset of peripheral neuropathy was 1.3 months (range 0.03 to 29.1). Of the patients who

experienced peripheral neuropathy, 28% had complete resolution and 13% had partial improvement (defined as

a decrease in severity by one or more grades from the worst grade) at last follow up. Peripheral neuropathy led

to discontinuation of ELAHERE in 0.4% of patients.

Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation,

neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening peripheral

neuropathy, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of

peripheral neuropathy [see Dosage and Administration (2.4)].

5.4 Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant

woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective

contraception during treatment with ELAHERE and for 7 months after the last dose [see Use in Specific

Populations (8.1, 8.3)].

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the labeling:

• Ocular Disorders [see Warnings and Precautions (5.1)].

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• Pneumonitis [see Warnings and Precautions (5.2)].

• Peripheral Neuropathy [see Warnings and Precautions (5.3)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the

clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not

reflect the rates observed in practice.

The pooled safety population described in WARNINGS AND PRECAUTIONS reflect exposure to ELAHERE

in 464 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer at 6 mg/kg AIBW

administered intravenously once every 3 weeks until disease progression or unacceptable toxicity in Study

0417; Study 0403 (NCT02631876), and Study 0401 (NCT01609556). The median duration of treatment was 4.3

months (range: 0.7 to 30.4).

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Study 0417

The safety of ELAHERE was evaluated in Study 0417, a single-arm, open-label study in patients (n=106) with

platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer [see Clinical Studies (14)].

Patients received ELAHERE 6 mg/kg AIBW once every 3 weeks until disease progression or unacceptable

toxicity. The median duration of treatment was 4.2 months (range: 0.7 to 13.3).

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were

intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions

occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).

Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most

common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and

thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment

(unilateral decrease to BCVA < 20/200 that resolved to baseline after discontinuation).

Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients treated with ELAHERE.

Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%),

keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%), and increased gamma-glutamyltransferase

(3%).

Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which

required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment,

fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy,

abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation,

increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils,

and decreased hemoglobin.

Table 4 summarizes the adverse reactions (≥10%) in patients treated with ELAHERE in Study 0417.

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Table 4: Adverse Reactions (≥10%) in Patients with Epithelial Ovarian, Fallopian Tube, or Primary

Peritoneal Cancer Who Received ELAHERE in Study 0417

Adverse Reaction

All Grades

N=106

(%)

Grade 3-4

N=106

(%)

Eye disorders

Vision impairment

※

50 7

Keratopathy

†

37 9

Dry eye

‡

27 2

Cataract 18 3

Photophobia 17 0

Eye Pain

10 0

General disorders

Fatigue 49 3

Gastrointestinal disorders

Nausea 40 0

Abdominal Pain

36 7

Diarrhea 31 3

Constipation 30 1

Vomiting 19 0

Abdominal distension 11 0

Nervous system disorders

Peripheral neuropathy

33 2

Metabolism and nutrition disorders

Decreased appetite 18 1

Musculoskeletal and connective tissue disorders

Arthralgia 17 0

Myalgia 10 0

Respiratory, thoracic, and mediastinal disorders

Dyspnea^ 12 0

※Visual Impairment includes vision blurred, vitreous floaters, visual acuity reduced, diplopia, presbyopia, accommodation disorder,

visual impairment, and refraction disorder.

† Keratopathy includes corneal disorder, corneal epithelial microcysts, corneal epithelial defect, keratitis, keratopathy, corneal

deposits, and punctate keratitis.

‡ Dry eye includes dry eye and lacrimation increased.

§ Eye pain includes eye pain and ocular discomfort.

⸙

Fatigue includes fatigue and asthenia.

* Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort.

Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia,

hypoesthesia, polyneuropathy, and neurotoxicity.

^ Dyspnea includes dyspnea and exertional dyspnea.

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Clinically relevant adverse reactions occurring in <10% of patients who received ELAHERE in Study 0417

included infusion related reactions/hypersensitivity (9%), pneumonitis (8%), thrombocytopenia (5%), and

uveitis (1%).

Table 5 summarizes the laboratory abnormalities in Study 0417.

Table 5: Select Laboratory Abnormalities ≥10% for All Grades, or ≥2% for Grades 3-4 in Patients Who

Received ELAHERE

Laboratory Abnormality

ELAHERE*

All Grades

(%)

Grade 3-4

(%)

Liver Function Tests

Increased aspartate

aminotransferase

50 2

Increased alanine aminotransferase 39 2

Increased alkaline phosphatase 30 1

Hematology*

Decreased lymphocytes 35 7

Decreased leukocytes 26 1

Decreased neutrophils 26 3

Decreased hemoglobin 25 3

Decreased platelets 18 2

Chemistry

Decreased albumin 31 1

Decreased magnesium 27 2

Increased creatinine 16 0

Decreased potassium 15 4

* The denominator used to calculate the rate varied from 98 to 101 based on the number of patients with a baseline value and at least

one post-treatment value.

7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on ELAHERE

Strong CYP3A4 Inhibitors

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase

unconjugated DM4 exposure [see Clinical Pharmacology (12.3)], which may increase the risk of ELAHERE

adverse reactions [see Adverse Reactions (6)]. Closely monitor patients for adverse reactions with ELAHERE

when used concomitantly with strong CYP3A4 inhibitors [see Warnings and Precautions (5)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

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Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant

woman because it contains a genotoxic compound (DM4) and affects actively dividing cells [see Clinical

Pharmacology (12.1), Nonclinical Toxicology (13.1)]. Human immunoglobulin G (IgG) is known to cross the

placental barrier; therefore, ELAHERE has the potential to be transmitted from the mother to the developing

fetus. There are no available human data on ELAHERE use in pregnant women to inform a drug-associated

risk. No reproductive or developmental animal toxicity studies were conducted with mirvetuximab

soravtansine-gynx. Advise patients of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data

Animal Data: No reproductive or developmental animal toxicity studies have been conducted with

mirvetuximab soravtansine-gynx. The cytotoxic component of ELAHERE, DM4, disrupts microtubule function,

is genotoxic, and can be toxic to actively dividing cells, suggesting it has the potential to cause embryotoxicity

and teratogenicity.

8.2 Lactation

Risk Summary

There are no data on the presence of mirvetuximab soravtansine-gynx in human milk or the effects on the

breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child,

advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

8.3 Females and Males of Reproductive Potential

ELAHERE can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific

Populations (8.1)].

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating ELAHERE.

Contraception

Females: Advise females of reproductive potential to use effective contraception during treatment with

ELAHERE and for 7 months after the last dose.

8.4 Pediatric Use

Safety and effectiveness of ELAHERE have not been established in pediatric patients.

8.5 Geriatric Use

Of the 106 patients who were treated in Study 0417, 44% of patients were ≥65 years old. Grade ≥3 adverse

reactions occurred in 49% of patients ≥65 years and in 51% <65 years. No clinically meaningful differences in

efficacy or safety were observed between patients ≥65 years of age compared to younger patients.

Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the

pharmacokinetics of ELAHERE [see Clinical Pharmacology (12.3)].

8.6 Renal Impairment

No dosage adjustment of ELAHERE is recommended for patients with mild to moderate renal impairment

(CLcr 30 to 90 mL/min). The effect of severe renal impairment (CLcr 15 to < 30 mL/min) or end-stage renal

disease on ELAHERE is unknown [see Clinical Pharmacology (12.3)].

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8.7 Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

No dosage adjustment of ELAHERE is recommended for patients with mild hepatic impairment (total bilirubin

≤ULN and AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST) [see Clinical Pharmacology

(12.3)].

11 DESCRIPTION

Mirvetuximab soravtansine-gynx is a folate receptor alpha (FRα)-directed antibody-drug conjugate (ADC)

consisting of three components: 1) an anti-FRα monoclonal antibody of IgG1 subtype 2) the small molecule

anti-tubulin agent DM4 (a maytansine derivative) and 3) a linker, sulfo-SPDB (1-(2,5-dioxopyrrolidin-1-yl)oxy-

1-oxo-4-(pyridin-2-yldisulfanyl)butane-2-sulfonic acid) that covalently attaches DM4 to the mirvetuximab

antibody. Mirvetuximab soravtansine-gynx has an approximate molecular weight of 150 kDa. An average of 3.4

molecules of DM4 are attached to each antibody molecule. Mirvetuximab soravtansine-gynx is produced by

chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian

(Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis.

Mirvetuximab soravtansine-gynx has the following structure:

ELAHERE (mirvetuximab soravtansine-gynx) injection is supplied as a sterile, preservative-free, clear to

slightly opalescent, colorless solution containing 100 mg/20 mL of mirvetuximab soravtansine-gynx in single-

dose vials. Each mL of solution contains 5 mg of mirvetuximab soravtansine-gynx, and glacial acetic acid (0.22

mg), polysorbate 20 (0.1 mg), sodium acetate (0.53 mg), sucrose (90 mg), and Water for Injection. The pH is

approximately 5.0.

The ELAHERE vial stoppers are not made with natural rubber latex.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1

directed against folate receptor alpha (FRα). The small molecule, DM4, is a microtubule inhibitor attached to

the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine-gynx is internalized

followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network

within the cell, resulting in cell cycle arrest and apoptotic cell death.

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12.2 Pharmacodynamics

Exposure-Response Relationships

An exposure-response relationship between mirvetuximab soravtansine-gynx and overall response rates was

observed. Higher incidence of Grade ≥2 ocular adverse reactions and Grade ≥2 peripheral neuropathy occurred

with increasing mirvetuximab soravtansine-gynx exposure.

Cardiac Electrophysiology

At the approved recommended dose, ELAHERE did not cause large mean increases (>10 msec) in the QTc

interval.

12.3 Pharmacokinetics

The pharmacokinetics were characterized after patients were administered mirvetuximab soravtansine-gynx

0.161 mg/kg to 8.71 mg/kg adjusted ideal body weight (AIBW) dosages, (0.0268 times to 1.45 times the

approved recommended dosage of 6 mg/kg AIBW), unless otherwise noted.

Table 6 summarizes the exposure parameters of mirvetuximab soravtansine-gynx, unconjugated DM4, and its

metabolite S-methyl-DM4 following administration after the first cycle (3-weeks) of mirvetuximab

soravtansine-gynx 6 mg/kg to patients. Peak mirvetuximab soravtansine-gynx concentrations were observed

near the end of intravenous infusion, while peak unconjugated DM4 concentrations were observed on the

second day after administration of mirvetuximab soravtansine-gynx, and the peak S-methyl-DM4

concentrations were observed approximately 3 days after administration of mirvetuximab soravtansine-gynx.

Steady state concentrations of mirvetuximab soravtansine-gynx, DM4, and S-methyl-DM4 were reached after 1

treatment cycle. Accumulation of the mirvetuximab soravtansine-gynx, DM4, and S-methyl-DM4 was minimal

following repeat administration of mirvetuximab soravtansine-gynx.

Table 6: Exposure Parameters of Mirvetuximab Soravtansine-gynx, Unconjugated DM4, and S-methyl

DM4 After First Treatment Cycle of 6 mg/kg of Mirvetuximab Soravtansine-gynx

Mirvetuximab Soravtansine-gynx

Mean (±SD)

Unconjugated DM4

Mean (±SD)

S-methyl-DM4

Mean (±SD)

max

137.3 (±62.3) µg/mL 4.11 (±2.29) ng/mL 6.98 (±6.79) ng/mL

AUC

tau

20.65 (±6.84) h*mg/mL 530 (±245) h*ng/mL 1848 (±1585) h*ng/mL

max

= maximum concentration, AUC

tau

= area under the concentration vs. time curve over the dosing interval (21 days).

Distribution

The mean (±SD) steady state volume of distribution of mirvetuximab soravtansine-gynx was 2.63 (±2.98) L.

Human plasma protein binding of DM4 and S-methyl DM4 was >99%, in vitro.

Elimination

Total plasma clearance (geometric mean [CV%]) of mirvetuximab soravtansine-gynx was 18.9 mL/hour

(51.9%). The geometric mean terminal phase half-life of mirvetuximab soravtansine-gynx after the first dose

was 4.8 days leading to a steady state at approximately 24 days. For the unconjugated DM4, the total plasma

clearance (geometric mean [CV%]) was 13.8 L/hour (31.1%) and the geometric mean terminal phase half-life

was 2.8 days. For S-methyl-DM4, the total plasma clearance (geometric mean [CV%]) was 4.3 L/hour (63.6%)

and the geometric mean terminal phase half-life was 5.0 days.

Metabolism

The monoclonal antibody portion of mirvetuximab soravtansine-gynx is expected to be metabolized into small

peptides by catabolic pathways. Unconjugated DM4 and S-methyl-DM4 undergo metabolism by CYP3A4. In

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human plasma, DM4 and S-methyl DM4 were identified as the main circulating metabolites, accounting for

approximately 0.4% and 1.4% of mirvetuximab soravtansine-gynx AUCs, respectively.

Excretion

S-methyl DM4 and DM4-sulfo-SPDB-lysine were detected in urine within 24 hours of infusion as the main

metabolites.

Specific Populations

No clinically significant differences in the pharmacokinetics of mirvetuximab soravtansine-gynx were observed

based on age (34 to 89 years), body weight (36 to 136 kg), mild hepatic impairment (total bilirubin ≤ULN and

any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST), or mild to moderate renal impairment

(CLcr ≥30 and <90 mL/min).

The pharmacokinetics of ELAHERE in patients with moderate to severe hepatic impairment (total bilirubin

>1.5 ULN with any AST) or severe renal impairment (CLcr 15 to 30 mL/min) is unknown.

Drug Interaction Studies

Clinical studies and model informed approaches

No clinical studies evaluating the drug-drug interaction potential of mirvetuximab soravtansine-gynx have been

conducted.

However, in 3 clinical trials, there were no differences in exposure between patients who received concomitant

weak or moderate CYP3A4 inhibitors or P-glycoprotein (P-gp) inhibitors and those who did not.

In Vitro Studies

Cytochrome P450 (CYP) Enzymes: Unconjugated DM4 is a time-dependent inhibitor of CYP3A4.

Unconjugated DM4 and S-methyl DM4 are not direct inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9,

CYP2C19, CYP2D6, or CYP3A. DM4 and S-methyl DM4 are not inducers of CYP1A2, CYP2B6, or

CYP3A4.

Transporter Systems: Unconjugated DM4 and S-methyl DM4 are substrates of P-gp but are not inhibitors of P-

gp.

12.6 Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation

against mirvetuximab soravtansine-gynx is highly dependent on the sensitivity and specificity of the assay. The

observed incidence of anti-drug antibodies (including neutralizing antibody) is highly dependent on the

sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the

incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies to

mirvetuximab soravtansine-gynx in other studies.

With a median duration of treatment of 4.3 months in Studies 0417, 0401, and 0403, a total of 55/423 (13%)

ovarian cancer patients treated with mirvetuximab soravtansine-gynx at 6 mg/kg AIBW had at least 1 post-

baseline positive sample for anti-mirvetuximab soravtansine-gynx antibodies. Of those patients, 28/423 patients

(7%) had developed treatment-emergent ADA and 3/423 patients (0.7%) had treatment-enhanced ADA.

Neutralizing antibodies were detected in 24/423 (6%) of patients.

Because of the low occurrence of anti-mirvetuximab soravtansine-gynx antibodies, the effect of these antibodies

on the pharmacokinetics, efficacy, and/or safety of mirvetuximab soravtansine-gynx is unknown.

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with mirvetuximab soravtansine-gynx or DM4.

DM4 and the metabolite, S-methyl DM4, were clastogenic in the in vivo rat bone marrow micronucleus study.

DM4 and S-methyl DM4 were not mutagenic in the bacterial reverse mutation (Ames) assay.

Fertility studies have not been conducted with mirvetuximab soravtansine-gynx or DM4.

14 CLINICAL STUDIES

The efficacy of ELAHERE was evaluated in Study 0417 (NCT04296890), a single-arm trial of patients with

FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (n=106).

Patients were permitted to receive up to three prior lines of systemic therapy. All patients were required to have

received prior bevacizumab. The trial enrolled patients whose tumors were positive for FRα expression as

determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Patients were excluded if they had corneal

disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious

interstitial lung disease.

Patients received ELAHERE 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every 3

weeks until disease progression or unacceptable toxicity. Tumor response assessments occurred every 6 weeks

for the first 36 weeks and every 12 weeks thereafter.

The major efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of

response (DOR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

The efficacy evaluable population included 104 patients with platinum-resistant disease, who had measurable

disease, and received at least one dose of ELAHERE. In these 104 patients, the median age was 62 years (range:

35 to 85); 96% were White, 2% were Asian, and 2% did not have race reported. Two percent of patients were

Hispanic or Latino. All patients had an ECOG PS of 0 (57%) or 1 (43%). Ten percent of patients had received 1

prior line of systemic therapy, 39% of patients had received 2 prior lines of systemic therapy, and 50% of

patients had received 3 prior lines of systemic therapy. All patients had received prior bevacizumab and 47%

had received a prior PARP inhibitor.

Efficacy results for Study 0417 are summarized in Table 7.

Table 7: Efficacy Results in Study 0417

ELAHERE

(N=104)

Confirmed Overall Response Rate

(95% CI)

31.7%

(22.9, 41.6)

Complete response rate 4.8%

Partial response rate 26.9%

Duration of Response N=33

Median duration of response, months

(95% CI)

6.9

(5.6, 9.7)

Investigator assessment.

Response assessment results using independent radiology review were consistent with investigator assessment.

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15 REFERENCES

“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Each ELAHERE (mirvetuximab soravtansine-gynx) injection carton (NDC 72903-853-01) contains:

• One single-dose vial containing 100 mg of mirvetuximab soravtansine-gynx in 20 mL (5 mg/mL) of

clear to slightly opalescent, colorless sterile solution.

Storage and Handling

Store ELAHERE vials upright in a refrigerator at 2°C to 8°C (36°F to 46°F) until the time of preparation in the

original carton to protect from light.

Do not freeze or shake.

ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Ocular Disorders

Inform patients about the need for eye exams before and during treatment with ELAHERE.

Advise patients to contact their healthcare provider promptly if they experience any visual changes. Advise

patients to use steroid eye drops and artificial tear substitutes [see Dosage and Administration (2.3) and

Warnings and Precautions (5.1)].

Pneumonitis

Advise patients to immediately report new or worsening respiratory symptoms [see Dosage and Administration

(2.3) and Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise female

patients to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations

(5.4, 8.1, 8.3)].

Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and

for 7 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose [see Use

in Specific Populations (8.2)].

Manufactured by:

ImmunoGen, Inc.

Waltham, MA 02451

1-781-895-0600

U.S. License XXXX

Reference ID: 5077370

ELAHERE is a trademark of ImmunoGen, Inc.

2022 ImmunoGen, Inc.

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MEDICATION GUIDE

ELAHERE (el-ah-HERE)

(mirvetuximab soravtansine-gynx)

injection, for intravenous use

What is the most important information I should know about ELAHERE?

ELAHERE can cause serious side effects, including:

• Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider

right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes,

sensitivity to light, eye pain, or new or worsening vision changes.

o Your healthcare provider will send you to see an eye care professional to check your eyes before you start

treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and

symptoms of eye problems.

o Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during

your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.

o Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your

healthcare provider.

See “What are the possible side effects of ELAHERE?” for more information about side effects.

What is ELAHERE?

ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube

cancer, or primary peritoneal cancer who:

• have not responded to or are no longer responding to treatment with platinum-based chemotherapy and

• have received 1 to 3 prior types of chemotherapy.

Your healthcare provider will perform a test to make sure that ELAHERE is right for you.

It is not known if ELAHERE is safe and effective in children.

Before receiving ELAHERE, tell your healthcare provider about all of your medical conditions, including if you:

• have vision or eye problems.

• have liver problems.

• are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider

right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.

Females who are able to become pregnant:

o Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.

o You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of

ELAHERE.

• are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not

breastfeed during treatment and for 1 month after your last dose of ELAHERE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may

cause side effects.

How will I receive ELAHERE?

• ELAHERE will be given to you by infusion into your vein (intravenous or IV).

• Before each dose of ELAHERE you will receive medicines to help prevent infusion related reactions, nausea, and

vomiting.

• ELAHERE is usually given every 3 weeks (21-day cycle). Your healthcare provider will decide how many cycles you

need.

What are the possible side effects of ELAHERE?

ELAHERE can cause serious side effects, including:

• See “What is the most important information I should know about ELAHERE?”

• Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may

lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble

breathing, shortness of breath, cough, or chest pain.

• Peripheral neuropathy. You may develop nerve problems called peripheral neuropathy during treatment with

ELAHERE. Your healthcare provider will monitor you for signs and symptoms of nerve problems.

Tell your healthcare

provider if you get new or worsening numbness or tingling in your hands or feet or muscle weakness.

The most common side effects of ELAHERE include:

• feeling tired

• diarrhea

• increased liver enzymes in the blood

• decreased albumin level in the blood

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• nausea

• constipation

• stomach-area (abdominal) pain • decreased magnesium level in the blood

• decreased red or white blood cell counts

Your healthcare provider may change your dose of ELAHERE, delay treatment, or completel

y stop treatment if you have

certain side effects.

These are not all of the possible side effects of ELAHERE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ELAHERE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more

information about ELAHERE, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for

information about ELAHERE that is written for healthcare professionals.

What are the ingredients in ELAHERE?

Active ingredient: mirvetuximab soravtansine-gynx

Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection.

Manufactured by: ImmunoGen, Inc., Waltham, MA 02451

U.S. License XXXX

ELAHERE

is a trademark owned by ImmunoGen, Inc.

2022 ImmunoGen, Inc.

For more information, go to www.immunogen.com or call 1-833-486-4646.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued 11 2022

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