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

The U.S. Food and Drug Administration has officially granted full approval to TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurring or metastatic cervical cancer following progression post chemotherapy. This announcement was made by its developers, Pfizer Inc. and Genmab A/S.

This approval was made based on the successful results from the global, Phase 3 innovaTV 301 clinical trial. The trial demonstrated a significant overall survival benefit for adult patients with previously treated recurrent or metastatic cervical cancer when treated with TIVDAK, as compared to chemotherapy. It also achieved its secondary goals which included progression-free survival and confirmed objective response rate.

However, the U.S Prescribing Information for TIVDACK carries a boxed warning for Ocular Toxicity. It also warns of possible peripheral neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, and embryo-fetal toxicity.

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