TIVDAK (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patients with Recurrent or Metastatic Cervical Cancer

Media Release

COPENHAGEN, Denmark; January 9, 2024

• TIVDAK sBLA accepted for priority review, FDA action date is May 9, 2024
• Submission based on positive results from global phase 3 innovaTV 301 trial demonstrating overall survival benefit of tisotumab vedotin-tftv over chemotherapy

Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (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.

The sBLA is supported by efficacy and safety data from the global, randomized Phase 3 innovaTV 301 trial (NCT04697628), in which tisotumab vedotin-tftv demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), as assessed by the investigator, in patients with recurrent or metastatic cervical cancer compared to chemotherapy. The safety profile of tisotumab vedotin-tftv in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information. In October 2023, results from the innovaTV 301 study were presented during the Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.

“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 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, 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.”