Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is supported by data from a late-stage study showing that the dual therapy nearly doubled median overall survival (OS) and median progression-free survival (PFS) compared to chemotherapy.
This data will be instrumental in bolstering global regulatory submissions and in converting the conditional approval for adult patients with la/mUC who are ineligible for cisplatin-containing chemotherapy into a full approval.
The successful pairing stems from a collaboration agreement between MSD and partners Astellas and Pfizer-acquired Seagen, focusing on untreated metastatic urothelial cancer.- Flcube.com
