Mashup Score: 2
U.S. Food and Drug AdministrationOn April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
Pembrolizumab + enfortumab-vedotin received accelerated approval for patients with locally advanced or metastatic urothelial carcinoma, ineligible for cisplatin-based chemotherapy. The data came from the cohorts A & K of EV-103 (phase Ib/II) trial showing very impressive ORR & DOR, while toxicity (about two/thirds of patients had >=G3 AEs) merits very close attention. We are waiting for the EV-302 (phase III) trial comparing Pembrolizumab + enfortumab-vedotin vs platinum-based chemotherapy (will be interested to see the % of patients who receive switch maintenance avelumab in that phase III trial)