Genmab A/S and Pfizer Inc. announced the FDA’s acceptance of the supplemental Biologics License Application (sBLA) to potentially convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval for patients with recurrent or metastatic cervical cancer who have progressed following first-line therapy. The sBLA has been granted Priority Review, with an action date set for May 9, 2024.

The sBLA submission is supported by data from the Phase 3 innovaTV 301 trial, where TIVDAK demonstrated superior overall survival, progression-free survival, and confirmed objective response rate compared to chemotherapy in patients with recurrent or metastatic cervical cancer. The safety profile of TIVDAK from the study was consistent with the known safety information.

Results from this trial were presented at ESMO Congress in October 2023. Genmab’s CEO, Jan van de Winkel, Ph.D., emphasized the need for therapeutic options that provide a survival advantage and represent new treatment approaches. Roger Dansey, M.D., Pfizer’s Chief Development Officer, Oncology, highlighted the FDA’s acceptance as crucial progress for providing an option that may extend the lives of adults with cervical cancer.

Cervical cancer remains a significant health concern, with over 13,960 new cases expected in the U.S. in 2023 alone, and an estimated 4,310 deaths. Despite advancements in prevention and early detection, there is a high need for better treatments for recurrent and/or metastatic cervical cancer—a devastating and mostly incurable condition.

The innovaTV 301 trial is a global, open-label Phase 3 study evaluating TIVDAK against investigator’s choice of chemotherapy, focusing on advanced cervical cancer. The goal of this trial, along with the sBLA, is to continue delivering TIVDAK as a viable treatment option for women in the U.S. who are affected by this aggressive disease.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.