In exciting treatment news, the Food and Drug Administration (FDA) has granted accelerated approval to mirvetuximab soravtansine-gynx (trade name Elahere, made by Immunogen, Inc.), for adults with folate receptor alpha (FRa) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have undergone one to three earlier systemic treatment regimens. The FDA also approved VENTANA FOLR1 (FOLR-2.1) RxDx Assay as a companion diagnostic test for FRa indication, to determine which patients are eligible for this treatment. Approximately 35% of ovarian cancer patients express high levels of FRa.
Mirvetuximab soravtansine-gynx is the first FDA-approved antibody-drug conjugate (ADC) — a type of targeted therapy — to treat platinum-resistant disease. It has been granted accelerated approval based on results from the SORAYA trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRa, and who had been treated with one to three prior systemic treatment regimens, with at least one including Avastin® (bevacizumab). Its continued approval may be contingent upon further assessment of clinical benefit in a confirmatory trial.
“The approval of ELAHERE is significant for patients with FRa-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes,” said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, SORAYA Co-Principal Investigator, and Grants Oversight Chair of OCRA’s Scientific Advisory Committee, in a press release from Immunogen, Inc.
“ELAHERE’s impressive anti-tumor 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.”