First Approval in Eight Years for Platinum-resistant Ovarian Cancer 

A targeted therapy was approved for a subset of treatment-resistant ovarian, fallopian tube, and peritoneal cancers. 

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers that express folate receptor alpha (FRα) and who have received prior systemic therapies.  

The FDA also approved the companion diagnostic VENTANA FOLR1 (FOLR-2.1) RxDx Assay to identify patients eligible for the therapy.  

Mirvetuximab soravtansine-gynx is a type of targeted therapy known as an antibody-drug conjugate and is designed to deliver a cytotoxic drug to cells that are positive for FRα. It is the first antibody-drug conjugate to be approved by the FDA to treat platinum-resistant ovarian cancer and marks the first FDA approval since 2014 for platinum-resistant ovarian cancer, which is associated with a poor prognosis. 

The approval is based on results from the single-arm phase III SORAYA clinical trial. The trial enrolled 106 patients with assay-confirmed FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received bevacizumab and up to three prior lines of systemic therapy.  

Among 104 evaluable patients, 31.7 percent experienced a response to the therapy, with a median duration of response of 6.9 months. 

The approval is accompanied by a boxed warning for ocular toxicity.  

It was estimated that ovarian, fallopian tube, and primary peritoneal cancers would be diagnosed in 19,880 individuals in the U.S. in 2022, and 12,810 patients would die from these cancers. 

The FDA rendered its decision on November 10, 2022. Accelerated approval means continued approval may be contingent upon a confirmatory trial.