Astellas and Seagen's Padcev wins full FDA approval, notching expanded label in tough-to-crack urothelial cancer
Two years after Seagen and Astellas won a conditional FDA approval to target urothelial cancer, the pair’s Padcev drug has been given a full endorsement from regulators.
The FDA granted full approval and a label expansion for Padcev to treat patients with advanced or metastatic urothelial cancer who aren’t eligible for cisplatin chemo, the company announced on Friday. Padcev is now available for second-line patients, and the OK is the first for those who have previously received immunotherapy and cannot receive cisplatin, the companies said.
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