Posted by Michael Wonder on 09 Apr 2021
Genmab and Seagen announce U.S. FDA filing acceptance for priority review of tisotumab vedotin biologics license application for patients with recurrent or metastatic cervical cancer
9 April 2021 - BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020.
Genmab and Seagen today announced that the U.S. FDA has accepted for priority review the biologics license application seeking accelerated approval for tisotumab vedotin.
This biologics license application requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act, the FDA has set a target action date of 10 October 2021.
