ImmunoGen Wins FDA Accelerated Approval For Ovarian Cancer Drug
Massachusetts, US-based ImmunoGen has made the transition to a fully-integrated oncology company after the US FDA gave accelerated approval for Elahere (mirvetuximab soravtansine-gynx) for platinum-resistant ovarian cancer.
Elahere is now the first antibody-drug conjugate (ADC) to be approved by the FDA for platinum-resistant disease. The drug consists of a FRα-binding antibody, a cleavable linker, and the maytansinoid payload DM4, a tubulin inhibitor designed to kill targeted cancer cells.
The approval covers adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens, regardless of prior Avastin (bevacizumab) use.
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Overall Response Rate Of 31.7%
Elahere’s approval is based on results from the pivotal Soraya trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα. They have also gone through one to three systemic therapies, at least one of which is Avastin.
Elahere met the primary endpoint of overall response rate (ORR), displaying a 31.7% ORR. The drug also met a key secondary endpoint, showing a median duration of response (DOR) of 6.9 months. The drug contains a boxed warning for toxicity to the eye that could result in visual impairment and dry eye among other adverse events. The most commonly reported side effects, experienced by at least 20% of patients, include vision impairment, fatigue, increased aspartate aminotransferase, and nausea.
The FDA has also given the green light to the Ventana FOLR1 (FOLR1-2.1) RxDx Assay, the only companion diagnostic to assess patients eligible for Elahere. The assay, developed by Roche, will be used to identify ovarian cancer patients with high levels of FRα which is expressed by up to 40% of ovarian cancer patients.
Mirasol, a confirmatory randomized trial that would seal full approval for Elahere, is fully enrolled with a topline readout expected in early 2023, said ImmunoGen.
“Platinum-resistant ovarian cancer is a notoriously challenging disease to treat,” said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. “Given there have been no new therapies approved by FDA for this indication since 2014, ELAHERE’s accelerated approval is a tremendous advance in the ovarian cancer treatment paradigm,” she said.©www.geneonline.com All rights reserved. Collaborate with us: firstname.lastname@example.org