US FDA Nods Pfizer & Genmab's Treatment For Cervical Cancer

The supplemental Biologics License Application (sBLA), filed on behalf of Pfizer Inc. and Genmab A/S, aims to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval for the treatment of patients with recurrent or metastatic cervical cancer whose disease progresses on or after first-line therapy. The FDA accepted the sBLA. With May 9, 2024 as the Prescription Drug User Fee Act (PDUFA) objective date, the application has been awarded Priority Review.

“The phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting Tivdak as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” said Roger Dansey, M.D., chief development officer, oncology at Pfizer. “The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer.”

The sBLA is supported by efficacy and safety data from the global, randomized, phase 3 innovaTV 301 trial (NCT04697628), in which Tivdak demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), as assessed by the investigator, in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy, as per pharmabiz.

“Therapeutic options for metastatic cervical cancer that not only demonstrate a survival advantage but also include a novel approach to treating this condition are needed,” said Jan van de Winkel, Ph.D., chief executive officer at Genmab. “This milestone underscores our commitment to continuing to deliver Tivdak as a treatment option to women in the US diagnosed with cervical cancer whose disease has progressed after first-line treatment.”