Pfizer,Genmab: FDA Grants Full Approval For TIVDAK To Treat Recurrent Or Metastatic Cervical Cancer

(RTTNews) - The U.S. Food and Drug Administration approved the supplemental Biologics License Application or sBLA granting full approval for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, Pfizer Inc. (PFE) and Genmab A/S (GMAB) said in a statement.

The approval was based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating overall survival benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy. Secondary endpoints of progression-free survival and confirmed objective response rate were also met.

The U.S. Prescribing Information for TIVDAK includes a BOXED WARNING for Ocular Toxicity as well as the following Warnings and Precautions: peripheral neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, and embryo-fetal toxicity.

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