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

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