AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use

November 20, 2020 Auto Bot AstraZenca, durvalumab, Imfinzi, P-lll, regulatory, US FDA’s 0

Shots:

  • The FDA has approved Imfinzi for an additional dosing option (1500mg, FD, q4w) in the approved indications of unresectable stage III NSCLC after CRT and prior treated advanced bladder cancer
  • The approval is based on multiple studies, including the P-III PACIFIC study which supported the 2wks., wt. based dosing in unresectable stage III NSCLC, and the P-III CASPIAN study which used 4wks. FD, during maintenance treatment in ES-SCLC
  • The new dosing option for Imfinzi is under regulatory review in multiple countries, including in the EU where the new dosing option was granted accelerated assessment

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Mint

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