U.S. Food and Drug Administration (FDA)-Approved Indications

Elahere is indicated for the treatment of adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

According to the prescribing information, Elahere carries the following black box warning of ocular toxicity:

Additional warnings and precautions per the prescribing information include:

Per the prescribing information, 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.

Refer to full prescribing information for Elahere for drug interactions and use in specific populations.

On November 14, 2022, the Food and Drug Administration granted accelerated approval to Elahere mirvetuximab soravtansine-gynx (Elahere) for 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. Patients are selected for therapy based on an FDA-approved test. The FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to select patients for the indication (FDA, 2022).

The FDA approval was based on supporting data from Study 0417 which evaluated efficacy of Elahere. The study was a a single-arm trial of 106 patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients were permitted to receive up to three prior lines of systemic therapy. All patients were required to have received bevacizumab. The trial enrolled patients whose tumors were positive for FRα expression as determined by the above 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 mirvetuximab soravtansine-gynx 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every three weeks until disease progression or unacceptable toxicity. Tumor response assessments occurred every six weeks for the first 36 weeks and every 12 weeks thereafter. The main efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of response (DOR). In the efficacy evaluable population of patients who had platinum resistant, measurable disease, and received at least one dose (104 patients), the confirmed ORR was 31.7% (95% Confidence Interval [CI]: 22.9, 41.6) and median DOR was 6.9 months (95% CI: 5.6, 9.7).

: Requires Precertification:

Precertification of mirvetuximab soravtansine-gynx (Elahere) is required of all Aetna participating providers and members in applicable plan designs. For precertification of mirvetuximab soravtansine-gynx (Elahere), call (866) 752-7021 (commercial), or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see

For Medicare Part B plans, call (866) 503-0857, or fax (844) 268-7263.

Criteria for Initial Approval

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Aetna considers mirvetuximab soravtansine-gynx (Elahere) medically necessary for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer when

of the following criteria are met:

Aetna considers all other indications as experimental and investigational.

Continuation of Therapy

Aetna considers continuation of mirvetuximab soravtansine-gynx (Elahere) therapy medically necessary in members requesting reauthorization for an indication listed in Section I when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Dosage and Administration

Mirvetuximab soravtansine-gynx is supplied as Elahere 100 mg/20 mL (5 mg/mL) in single-dose vial for injection for intravenous use.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The recommended dose of Elahere is 6 mg/kg adjusted ideal body weight (AIBW) given once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity.

Refer to full prescribing information for Elahere

dosage modifications.

Source: ImmunoGen, 2022