LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy for limited-stage small cell lung cancer. The CHMP of the European Medicines Agency based its positive opinion on the results from the ADRIATIC Phase III trial. The company noted that the safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine.
Imfinzi is approved in the US and several other countries in this setting. The company noted that regulatory applications are currently under review in Japan and several other countries in this indication.
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