FDA grants Breakthrough Therapy Designation for Astellas’ and Seattle Genetics’ agent Padcev in bladder cancer indication

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FDA has granted Breakthrough Therapy designation for Padcevtm in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

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