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

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…

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