Tivdak (tisotumab vedotin-tftv) supplemental biologics license application accepted by the FDA for patients with recurrent or metastatic cervical cancer
Genmab A/S and Pfizer, Inc. announced today that the FDA has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy
The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024.
“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, Genmab. “This milestone underscores our commitment to continuing to deliver Tivdak as a treatment option to women in the U.S. diagnosed with cervical cancer whose disease has progressed after first-line treatment.”
“The Phase III 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, 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.”
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