Is Mirvetuximab soravtansine-gynx on the market?

On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Mirvetuximab soravtansine-gynx for the treatment of adult patients with folate receptor-alpha (FR-alpha)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have received 1 to 3 previous systemic treatments. The VENTANA forl 1 (FOLR-2.1) RxDx test is approved as an adjunctive diagnostic device for use in selected patients for this indication. Milvituximab is sold under the trade name Elahere.

Mivituximab is the first approved targeted therapy forFRα-positive, platinum-resistant ovarian cancer, and the first approved antibody-drug conjugate for ovarian cancer. Approval was based on Study 0417, a single-arm, multicenter trial of 106 participants with FR-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were allowed to receive up to three systemic therapies. Among 104 patients with measurable disease who received milvituximab, the overall response rate was 31.7% and the median duration of response was 6.9 months.

Ocular toxicity is listed as a boxed warning in the United States Prescribing Information (USPI) to alert providers of the risk of serious ocular toxicity, including visual impairment and corneal disease. Pneumonitis and peripheral neuropathy are other important safety risks listed as Warnings and Precautions in the USPI.

Since milvituximab has been on the market for a short time, there may be less information on its price and other related information.