Pfizer : FDA Approves Padcev-Keytruda To Treat Advanced Bladder Cancer

(RTTNews) - The U.S. Food and Drug Administration approved Padcev (enfortumab vedotin-ejfv, an antibody-drug conjugate) with Keytruda (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer, Pfizer Inc. (PFE) and Astellas Pharma said in a statement.

The company noted that the combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer or la/mUC.

The approval was based on results from the Phase 3 EV-302 clinical trial, which demonstrated the combination nearly doubled median overall survival and median progression-free survival in patients with previously untreated la/mUC compared to platinum-containing chemotherapy.

Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs.

If bladder cancer has spread to surrounding organs or muscles, it is called locally advanced disease. If the cancer has spread to other parts of the body, it is called metastatic disease.

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