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The FDA has granted full approval for TIVDAK® for the treatment of recurrent or metastatic cervical cancer. TIVDAK is the first antibody-drug conjugate with positive overall survival data for patients with previously treated disease. The approval is based on results from a Phase 3 study showing an overall survival benefit compared to chemotherapy. The safety profile of TIVDAK was consistent with known information, with no new safety issues identified. Common adverse reactions included decreased hemoglobin, peripheral neuropathy, and conjunctival adverse reactions. The approval of TIVDAK brings new treatment options for patients with advanced cervical cancer and addresses the high unmet need in this patient population.
Genmab A/S and Pfizer Inc. announced that the U.S. FDA has approved TIVDAK® for recurrent or metastatic cervical cancer treatment, converting its accelerated approval to a full approval. This is the first ADC with positive overall survival data in this patient population. The approval is based on Phase 3 data showing a 30% risk reduction in death compared to chemotherapy.