Posted by Michael Wonder on 18 Aug 2020
Imfinzi granted FDA priority review for less-frequent, fixed-dose use
18 August 2020 - Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits by half.
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
If approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in unresectable Stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer, consistent with the approved dosing in extensive-stage small cell lung cancer (ES-SCLC).
