FDA accepts Tivdak sBLA for priority review

The 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, which came form US pharma giant Pfizer (NYSE: PFE) and partner Denmark’s Genmab (OMX: GEN), has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.

Tivdak was granted accelerated approval in the USA by the FDA in September 2021. Pfizer acquired right to the drug along with its $43 billion acquisition of Seagen, which completed last month. Third-quarter 2023 sales of Tivdak reported by Seagen were $23 million.