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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Throughout my career as a physician and scientist, I’ve seen ideas once considered impossible become breakthroughs that save lives. They happened because talented scientists had the resources, institutions, and sustained support to pursue ambitious ideas. Most importantly, they knew patients could not afford to wait. 

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