The FDA has granted priority review to a supplemental biologics license application for enfortumab vedotin plus pembrolizumab for the frontline treatment of patients with locally advanced or metastatic urothelial cancer.
The FDA has approved enzalutamide for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
The approval makes enzalutamide the first and only androgen receptor-signaling inhibitor approved for the treatment of nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastatic.
Investigators reported that enfortumab vedotin-ejfv (Padcev; Astella Pharma Inc, Seagen Inc) in combination with pembrolizumab (Keytruda; Merck & Co Inc) met the dual primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic urothelial cancer.
The European Medicines Agency has accepted a marketing authorization application seeking the approval of zolbetuximab for first-line treatment of patients with Claudin18.2-positive, HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.