11:16 AM EDT, 04/30/2024 (MT Newswires) -- Pfizer ( PFE ) and Genmab ( GMAB ) said Monday that the US Food and Drug Administration approved a supplemental biologics license application for Tivak to treat patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The approval comes after the application received a priority review designation by the regulator, the companies added.

Tivak, or tisotumab vedotin-tftv, is an antibody-drug conjugate composed of Genmab's ( GMAB ) human monoclonal antibody directed to tissue factor and Pfizer's ( PFE ) ADC technology, the companies said.

The approval is based on results from a phase 3 trial that met its primary endpoint of demonstrating overall survival benefit in adults with previously treated recurrent or metastatic cervical cancer treated with Tivak compared to chemotherapy, the companies said.

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