AstraZeneca (AZN) and Japan-based partner Daiichi Sankyo announced that the European Commission has approved their antibody-drug conjugate (ADC) Enhertu as a monotherapy for previously treated HER2-positive solid tumors. This marks Enhertu’s sixth approval in the European Union. The approval is based on positive results from phase II trials indicating clinically meaningful responses across various tumors.
Additionally, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Datroway (datopotamab deruxtecan) as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) ineligible for PD-1/PD-L1 inhibitors. The recommendation is supported by data from the phase III TROPION-Breast02 study, highlighting significant improvements in overall survival compared to chemotherapy.
Following Enhertu’s EU approval, AstraZeneca will pay a milestone of $25 million to Daiichi Sankyo as per their collaboration agreement, which began in March 2019. Year-to-date, AstraZeneca’s shares have increased by 2.5%, while the industry has seen a growth of 5.2%.
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