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EU CHMP recommends approval of Enhertu as adjuvant treatment for HER2-positive early breast cancer with residual disease
AZNAstrazeneca PLC
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Enhertu as an adjuvant treatment for HER2-positive early breast cancer with residual disease. This recommendation is based on the DESTINY-Breast05 Phase III trial, which demonstrated that Enhertu reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine (T-DM1). At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease versus 83.7% for T-DM1. AstraZeneca PLC is a global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines.