LONDON (dpa-AFX) - AstraZeneca PLC (AZN) on Monday said Imfinzi in combination with standard-of-care FLOT chemotherapy has been approved in the European Union for the treatment of adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
The FLOT regimen consists of fluorouracil, leucovorin, oxaliplatin and docetaxel. The treatment plan includes two cycles of Imfinzi combined with chemotherapy before and after surgery, followed by Imfinzi monotherapy.
The approval was based on results from the MATTERHORN Phase III trial in which patients treated with the Imfinzi-based perioperative regimen showed statistically significant and clinically meaningful improvements in event-free survival and overall survival.
Imfinzi in combination with FLOT chemotherapy has already been approved in the U.S. and several other countries. Regulatory applications for this indication are currently under review in Japan and other markets.
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