Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced 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) goal date of May 9, 2024.
NNPA Sponsor Pfizer’s Submission of Cancer Drug Accepted for Priority Review by FDA
