What is Mirvetuximab soravtansine-gynx?

Mirvetuximab soravtansine-gynx is a folate receptor-alpha (FR-alpha)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Most patients with ovarian cancer will undergo surgery followed by platinum-based chemotherapy, however most patients eventually develop platinum-resistant disease, which is difficult to treat.

Mivituximab is the first antibody-drug conjugate targetingFR-α, a cell surface protein highly expressed in ovarian cancer. The antibody is a chimeric IgG1 directed against FR-α, and the small molecule DM4 is a microtubule inhibitor designed to kill targeted cancer cells. It is attached to the antibody via a cleavable linker. Mivituximab was approved under the U.S. Food and Drug Administration's (FDA) accelerated approval program based on objective response rate (ORR) and duration of response (DOR) data from the pivot SORAYA trial.

The VENTANA FOLR1 (FOLR1-2.1) RxDx test is a diagnostic adjunct that helps identify patients eligible for milvituximab treatment. Approximately 35-40% of patients with ovarian cancer express high levels of FR-α, and newly diagnosed patients can be tested at diagnosis to determine whether mituximab is an option for patients if they progress to platinum resistance.

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