LONDON (dpa-AFX) - 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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