FDA Approves Elahere for Platinum-Resistant Gynecologic Cancers

The Food and Drug Administration (FDA) granted an accelerated approval to Elahere (mirvetuximab soravtansine-gynx) for the treatment of patients with folate receptor alpha (FRα)-positive platinum-resistant gynecological cancers who have undergone one to three prior systemic treatment regimens, according to ImmunoGen, the manufacturer of the drug.

The accelerated approval includes patients with epithelial ovarian, fallopian tube or primary peritoneal cancer, and was based on findings from the SORAYA clinical trial.

"The approval of Elahere is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes," Dr. Ursula Matulonis, chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, professor of Medicine at the Harvard Medical School, and SORAYA co-principal investigator, said in a company-issued press release.

The SORAYA trial included 106 patients with FRα-positive, platinum-resistant ovarian cancer who had been treated with one to three prior systemic treatment regimens, including Avastin (bevacizumab).

The main goal of the trial was overall response rate (percentage of patients whose disease shrinks or disappears as a result of treatment), and the secondary goal was duration of response.

The overall response rate was 31.7%, with five patients experiencing a complete response, meaning that there was no evidence of cancer after treatment. The average duration of response was 6.9 months.

Safety data from SORAYA was gathered from a larger population of study participants — 464 patients with epithelial ovarian, fallopian tube or primary peritoneal cancer. The FDA issued a boxed warning for Elahere for ocular (eye-related) toxicity, including visual impairment, keratopathy (cornea disease), dry eye, light sensitivity, eye pain and uveitis (eye inflammation).

The most common side effects from Elahere, which occurred in 20% or more of patients were: vision impairment, fatigue, increased aspartate aminotransferase and/or alanine aminotransferase (which could indicate liver damage), nausea, keratopathy, abdominal pain, decreased lymphocytes and/or leukocytes and neutrophils (types of white blood cells), peripheral neuropathy (pain and tingling in the hands and feet), diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium and decreased hemoglobin (red blood cells).

The FDA also approved a companion diagnostic, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, which will be used to identify patients who are eligible for treatment with Elahere by measuring levels of FRα found in tumor samples.

The accelerated approval of Elahere may be moved to a full approval based on findings from the MIRASOL confirmatory trial. Findings for this study are expected to be published in early 2023.

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