New indication for Enhertu approved in the EU

Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Enhertu, a specifically engineered HER2 directed antibody drug conjugate (ADC), is being jointly developed and commercialized by UK pharma major AstraZeneca (LSE: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). AstraZeneca reported first-half 2023 sales for Enhertu of $104 million and alliance revenues of $475 million.

The approval by the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use and is based on results from the  DESTINY-Lung02 Phase II trial presented at the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the  Journal of Clinical Oncology.