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AstraZeneca Says Enhertu Received Positive Recommendations From CHMP For Gastric Cancer

AstraZeneca PLC (AZN.L) and Daiichi Sankyo's Enhertu received positive recommendation from European Union's Committee for Medicinal Products for Human Use (CHMP) to treat adults patients with HER2-positive gastric cancer, AstraZeneca said in a statement.

The positive opinion from the CHMP was based on results from the DESTINY-Gastric02 and the DESTINY-Gastric01 Phase II trials.

In DESTINY-Gastric02 study, Enhertu showed clinically meaningful efficacy, and improved overall survival compared to chemotherapy, was observed in DESTINY-Gastric01 study.

"If approved, Enhertu would be the first HER2-directed medicine for patients with advanced gastric cancer in the European Union in more than a decade,"said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.

Enhertu is already approved in many countries including the US for locally advanced or metastatic HER2-positive gastric cancer.

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