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
Ref: AstraZeneca | Image: Mint
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