The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical cancer in patients who have been previously treated. The submission for full registration is supported by data from a late-stage trial, which demonstrated improvements in overall survival (OS), progression-free survival (PFS), and confirmed objective response rate (ORR) when compared to chemotherapy.
The positive results from this trial will also form the basis for regulatory submissions of Tivdak in other markets, potentially expanding access to this treatment for more patients globally.- Flcube.com
