AstraZeneca and Daiichi Sankyo’s Enhertu recommended for EU approval

AstraZeneca and Daiichi Sankyo’s Enhertu has been recommended for approval in the European Union (EU) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). Specifically designed for tumors with an activating HER2 (ERBB2) mutation, the drug aims to fill a significant gap in systemic therapy options following platinum-based chemotherapy.

Enhertu’s EU Recommendation Backed by Strong Clinical Trials

The EU’s Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its recommendation on compelling data from the DESTINY-Lung02 Phase II trial. Presented at the IASLC 2023 World Conference on Lung Cancer, the trial showed Enhertu’s confirmed objective response rate (ORR) at 49.0% and a disease control rate (DCR) of 93.1%. These statistics further strengthen the case for Enhertu as an effective treatment for advanced or metastatic HER2-mutant (HER2m) NSCLC.

Medical Experts Weigh In On Enhertu’s Potential

Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, emphasized the urgency of addressing HER2-mutant non-small cell lung cancer, which typically affects younger patients and has limited therapy options. “Enhertu will provide the first targeted treatment option for these patients,” said Galbraith. Similarly, Ken Takeshita, Global Head, R&D, Daiichi Sankyo, remarked that the CHMP opinion marks a significant step in making this HER2-directed antibody drug conjugate available to patients in need.

Safety Profile of Enhertu Confirmed

Adding to its promising potential, the safety profile of Enhertu in the DESTINY-Lung02 trial was found to be consistent with previous clinical studies, registering no new safety concerns. The trial’s results support the targeted therapy’s strong and durable tumor response, making it a much-needed option for patients with previously treated HER2-mutant advanced NSCLC.