FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.

Autor:	Dilawari A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Shah M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ison G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gittleman H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Shah A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hamed SS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Manheng W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pragani R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Arudchandran A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Patel P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zaman S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Roy A; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Kalavar S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Ghosh S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Rahman NA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mixter BD; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 Oct 02; Vol. 29 (19), pp. 3835-3840.
DOI:	10.1158/1078-0432.CCR-23-0991
Abstrakt:	On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx for treatment of adult patients with folate receptor-α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic therapies. The VENTANA FOLR1 (FOLR-2.1) RxDx Assay was approved as a companion diagnostic device to select patients for this indication. Approval was based on Study 0417 (SORAYA, NCT04296890), a single-arm, multicenter trial. In 104 patients with measurable disease who received mirvetuximab soravtansine-gynx, the overall response rate was 31.7% [95% confidence interval (CI), 22.9-41.6] with a median duration of response of 6.9 months (95% CI, 5.6-9.7). Ocular toxicity was included as a Boxed Warning in the U.S. Prescribing Information (USPI) to alert providers of the risks of developing severe ocular toxicity including vision impairment and corneal disorders. Pneumonitis and peripheral neuropathy were additional important safety risks included as Warnings and Precautions in the USPI. This is the first approval of a targeted therapy for FRα-positive, platinum-resistant ovarian cancer and the first antibody-drug conjugate approved for ovarian cancer. This article summarizes the favorable benefit-risk assessment leading to FDA's approval of mirvetuximab soravtansine-gynx. (©2023 American Association for Cancer Research.)
Databáze:	MEDLINE
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