Mirvetuximab Soravtansine

What it is and how it works

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.

Indications

® 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 . 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 )

Dosage and administration (summary)

Administer ELAHERE as an intravenous infusion only after dilution in 5% Dextrose Injection, USP. ELAHERE is incompatible with normal saline. 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. Premedicate with a corticosteroid, antihistamine, and antipyretic. 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.

Contraindications

None. None.

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.

Pregnancy

Pregnancy Risk Summary 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 . Human immunoglobulin G (IgG) is known to cross the placental barrier.

Storage and supply

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.

Source: Mirvetuximab Soravtansine (Elahere) — US FDA prescribing information, 2025-07-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.