AstraZeneca PLC (AZN) on Tuesday said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Enhertu, co-developed with Daiichi Sankyo Company Limited (DSKYF), for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have received prior treatment and have no satisfactory treatment options.
The positive opinion was based on results from subgroup analyses across the Phase II DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials, where Enhertu showed clinically meaningful responses in patients with HER2-positive tumours across multiple cancer types.
Enhertu is already approved in multiple countries for several cancers, including breast cancer, non-small cell lung cancer, gastric cancer and certain solid tumours.
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