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The FDA granted for the antibody-drug conjugate (ADC) mirvetuximab soravtansine (Elahere) for folate receptor α (FRα)-positive platinum-resistant ovarian cancer.

The action makes mirvetuximab the first ADC with an indication for platinum-resistant ovarian cancer. The indication includes patients who have received one to three prior systemic therapies for platinum-resistant disease. At the same time, the FDA approved the Ventana FOLR1 (FOLR1-2.1) RxDx Assay as a companion diagnostic to identify patients eligible for mirvetuximab.

Principal support for the conditional approval came from the single-arm SORAYA trial that included 106 patients with previously treated FRα-positive platinum-resistant ovarian cancer. The trial had an overall response rate of 31.7%, including five complete responses, and a median response duration of 6.9 months.

"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," said Ursula Matulonis, MD, of Dana-Farber Cancer Institute in Boston, in a from ImmunoGen. "Elahere's impressive antitumor activity, durability of response, and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option, and I look forward to treating patients with Elahere."

A safety analysis that included 464 patients who received at least one dose of mirvetuximab showed that the most common adverse events (≥20% of patients) were vision impairment, fatigue, increased aspartate aminotransferase or alanine aminotransferase, nausea, 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.

Prescribing information includes a boxed warning about ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.

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