The drug was being studied in patients with types of urothelial carcinoma who are eligible for cisplatin-based chemotherapy.

The FDA has approved the combination regimen of Merck’s Keytruda (pembrolizumab) and Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) for the first-line treatment of locally advanced or metastatic urothelial carcinoma, the companies announced Monday.

Merck’s Keytruda (pembrolizumab) has taken another hit after the drug failed to meet dual primary endpoints in the Phase III KEYNOTE-921 trial for metastatic castration-resistant prostate cancer (mCRPC).