FDA approves mirvetuximab soravtansine-gynx for subset of women with ovarian cancer
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The FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of certain adults with epithelial ovarian, fallopian tube or primary peritoneal cancer.
The indication for mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) applies to women with folate receptor alpha-positive, platinum-resistant disease who received one to three prior systemic treatment regimens.
FDA also approved a companion diagnostic device, the Ventana FOLR1 (FOLR-2.1) RxDx assay (Ventana Medical Systems, Inc.), to select women for treatment with the agent.
Mirvetuximab soravtansine-gynx, an antibody-drug conjugate, comprises a folate receptor alpha-directed antibody, cleavable linker and potent tubulin inhibitor.
FDA based the approval on results of the single-arm, phase 3 SORAYA trial, which enrolled 106 women with platinum-resistant ovarian cancer whose tumors expressed high levels of folate alpha-positive and who had been treated with as many as three systemic treatment regimens, one of which must have included bevacizumab (Avastin, Genentech). Women received 6 mg/kg mirvetuximab soravtansine-gynx based on adjusted ideal body weight via IV every 3 weeks until disease progression or unacceptable toxicity.
Investigator-assessed overall response rate served as the primary endpoint, with duration of response as a secondary endpoint.
Results showed a confirmed ORR of 31.7% (95% CI, 22.9-41.6) and median duration of response of 6.9 months (95% CI, 5.6-9.7).
"The approval of Elahere is significant for patients with [folate receptor alpha]-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes," Ursula A. Matulonis, MD, chief of the division of gynecologic oncology at Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School and SORAYA co-principal investigator, said in an ImmunoGen press release. “Elahere’s impressive antitumor activity, durability of response and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option."
The prescribing information for Elahere includes a boxed warning for ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain and uveitis. The most common adverse reactions, occurring in 20% or more of patients, included vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy and abdominal pain.
"Platinum-resistant ovarian cancer is a notoriously challenging disease to treat,” Anna Berkenblit, MD, senior vice president and chief medical officer of ImmunoGen, said in the release. “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.”
References:
- FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRa positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer (press release). Available at www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant. Published Nov. 14, 2022. Accessed Nov. 16, 2022.
- ImmunoGen announces FDA accelerated approval of Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer (press release). Available at investor.immunogen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm. Published Nov. 14, 2022. Accessed Nov. 16, 2022.
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