Biologics License Application for Tisotumab Vedotin to Treat Patients With Cervical Cancer Is Submitted to FDA

Seagen and Genmab hope to receive accelerated approval from the FDA for tisotumab vedotin monotherapy as treatment for patients with cervical cancer in the recurrent or metastatic setting.

SeaGen Inc. and Genmab A/S submitted a Biologics License Application (BLA) to the FDA in hopes of receiving accelerated approval for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, according to a press release.

This submission comes on the heels of meaningful data from the single-arm phase 2 innovaTV 204 trial (NCT03438396) investigating tisotumab vedotin monotherapy in this group of patients.

“This BLA submission is an important step toward our goal of improving the lives of women with recurrent or metastatic cervical cancer. I would like to thank the patients, nurses, physicians, and researchers who participated in the innovaTV 204 trial, which is the basis of this submission,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a press release. “We believe, if approved, tisotumab vedotin as monotherapy has the potential to become an important treatment option for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy.”

The patients included in the ongoing global, multicenter study had recurrent or metastatic cervical cancer and were previously treated with doublet chemotherapy with or without bevacizumab (Avastin). A total of 101 patients were treated with tisotumab vedotin at various centers in both the United States and Europe.

The primary end point of the phase 2 trial was confirmed objective response rate, with secondary end points including duration of response, progression-free survival, and overall survival.

Tisotumab vedotin is an investigational antibody drug conjugate (ADC) directed to tissue factor, which is a cell-surface protein associated with tumor growth, angiogenesis, metastasis, and poor prognosis, according to the research team.

“In the pivotal phase 2 study, tisotumab vedotin induced clinically meaningful and durable responses in this difficult-to-treat cervical cancer patient population, with a manageable and tolerable safety profile,” Roger Dansey, MD, chief medical officer at Seagen, said in a press release.

Results from the study were announced in June 2020 and presented in detail at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

In the United States, it is expected that over 13,500 women will be diagnosed with invasive cervical cancer and over 4200 will die from the disease in 2020. Cervical cancer continues to be a leading cause of cancer death for women, accounting for over 311,000 deaths annually worldwide. Despite the advances with human papillomavirus vaccines, women continue to be diagnosed with cervical cancer.

“Today’s submission marks an important milestone for tisotumab vedotin and a potential advance for patients with recurrent or metastatic cervical cancer for whom there is a high unmet need for effective new therapies,” said Dansey in a press release. “We look forward to working with the FDA on the review of the application.”


Seagen and Genmab Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer. News release. Seagen, Inc. and Genmab A/S. Published February 10, 2021. Accessed February 11, 2021.