Astellas and Seattle Genetics’ Padcev (enfortumab vedotin-ejfv) + Keytruda Receive FDA’s Breakthrough Therapy Designation as 1L Treatment for Advanced Bladder Cancer

Astellas and Seattle Genetics’ Padcev (enfortumab vedotin-ejfv) + Keytruda Receive FDA’s Breakthrough Therapy Designation as 1L Treatment for Advanced Bladder Cancer

Shots:

  • The BT designation is based on P-Ib/II EV-103 study assessing Padcev + Keytruda (pembrolizumab) in patients with LA/ mUC who are unable to receive cisplatin-based CT treated in the 1L setting
  • The FDA’s BT designation expedite the development and review of drugs that are intended to treat a serious or life-threatening condition
  • Padcev is an ADC targeting Nectin 4 and has received the US FDA’s approval in Dec’2019, indicated for LA/mUC in patients prior treated with PD-1/PD-L1 and platinum-containing CT before & after surgery

Click here ­to­ read full press release/ article | Ref: Astellas | Image: The Pharma letter