NEW YORK - Pfizer Inc. (NYSE:PFE) and Genmab A/S (Nasdaq:NASDAQ:GMAB) have reached a significant milestone as the U.S. Food and Drug Administration (FDA) accepted their supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) under Priority Review. This advanced regulatory step is aimed at securing full approval for TIVDAK as a treatment option for patients with recurrent or metastatic cervical cancer who have not responded to first-line therapy.
The Priority Review status accelerates the review timeline with a Prescription Drug User Fee Act (PDUFA) goal date set for May 9, 2024. This expedited review is a testament to the promising results of the global Phase 3 innovaTV 301 trial, which showcased TIVDAK's survival benefits compared to standard chemotherapy.
TIVDAK initially received accelerated approval from the FDA in September 2021. The transition from accelerated to full approval is a critical phase that often hinges on subsequent trial results confirming the drug's clinical benefits. Pfizer and Genmab's joint efforts in the development and profit-sharing of TIVDAK are part of a strategic collaboration following Pfizer's acquisition of Seagen, a move that has bolstered their oncology portfolio.
The acceptance of the sBLA by the FDA marks an important step toward providing a new therapeutic option for patients battling recurrent or metastatic cervical cancer, a condition with limited treatment choices and a high unmet medical need.
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