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The FDA has approved a combination therapy of Pfizer (NYSE:PFE) and Astellas’ (OTCPK:ALPMY) (OTCPK:ALPMF) drug Padcev and Merck’s (NYSE:MRK) Keytruda for the treatment of locally advanced or metastatic urothelial cancer, a common type of bladder cancer.
Pfizer said that the combined therapy is the first approved alternative to platinum-containing chemotherapy, the current standard of care for first-line urothelial cancer. Padcev, which was already approved to treat the disease, is an antibody drug conjugate while Keytruda belongs to a class of drugs known as PD-1 inhibitors.
Merck noted that the approval comes nearly five months ahead of the FDA’s decision target date of May 9.
Merck’s Keytruda was already approved for the treatment of several types of cancer, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, Hodgkin lymphoma, cervical cancer and gastric cancer.
Padcev was developed by Astellas and Seagen, which was recently acquired by Pfizer.
