Ovarian CancerFDA Approvals, News & Updates

Elahere FDA Approved for Patients with FRα-Positive, Platinum-Resistant Ovarian Cancer

December 2022 Vol 8 No 6

In November 2022, the FDA approved Elahere (mirvetuximab soravtansine-gynx; from ImmunoGen), an FRα inhibitor, for the treatment of adults with FRα-positive platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer after 1 to 3 systemic treatments. Elahere is the first FRα-directed antibody–drug conjugate approved by the FDA.

Patients should be identified for treatment with Elahere by an FDA-approved test that was approved on the same day as this new drug.

Ursula Matulonis, MD

“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, Chief, Division of Gynecologic Oncology, Dana-Farber Cancer Institute, Boston, and co-principal investigator of the SORAYA study. “Elahere’s impressive anti-tumor activity, durability of response, and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option.”

The FDA approved Elahere based on results of a clinical trial in 106 patients with FRα-positive, platinum-resistant epithelial ovarian cancer. The drug’s safety was evaluated in a pooled analysis of 3 studies that included 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

All patients received Elahere as an IV infusion every 3 weeks, until disease progression or unacceptable side effects. The response to Elahere was evaluated every 6 weeks for the first 36 weeks, and every 12 weeks thereafter.

Among the 104 patients with platinum-resistant epithelial ovarian cancer who received 1 or more doses of Elahere, 31.7% of patients had a response to therapy, including 5 complete responses (no sign of cancer), and the average response lasted 6.9 months.

Elahere is associated with serious ocular side effects that must be carefully monitored. The most common side effects with Elahere were vision problems, dry eye, fatigue, nausea, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, and abnormal laboratory test results.

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Last modified: January 3, 2023

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