LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) said Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer. The decision follows the Priority Review granted by the FDA in August 2020.
The company noted that the four-week 1,500mg fixed-dosing option for Imfinzi is also under regulatory review in several other countries, including in the EU where the new dosing option was granted accelerated assessment.
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