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Tuesday, August 18, 2020

FDA accepts AstraZeneca application for new dosing regimen for Imfinzi

Under Priority Review status, the FDA has accepted AstraZeneca’s (NYSE:AZN) supplemental marketing application seeking approval of a four-week, fixed-dose regimen for PD-L1 blocker Imfinzi (durvalumab) for non-small cell lung cancer and bladder cancer.

The current regimen is weight-based (10 mg/kg) dosing every two weeks.


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