FDA gives Padcev + Ketruda combination priority review sBLA in metastatic urothelial cancer
Astellas Pharma, Seagen Inc. and Merck announced the FDA has accepted for priority review supplemental Biologics License Applications (sBLAs) for Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy
The respective applications are intended to expand both labels for Padcev and Keytruda. The agency set a Prescription Drug User Fee Act (PDUFA) goal date for each application of April 21, 2023.
The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020. The respective sBLAs are supported by efficacy and safety data from the Phase Ib/II EV-103 trial (NCT03288545, also known as KEYNOTE-869) Dose Escalation/Cohort A and Cohort K. Results from Dose Escalation/Cohort A were published in the Journal of Clinical Oncology. Results from Cohort K were presented in a late-breaking session at the 2022 European Society for Medical Oncology Congress.
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