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AstraZeneca PLC on Friday said it has received approval in the EU for two different treatments for breast and lung cancer. The Cambridge, England-based pharmaceuticals firm said Enhertu, or trastuzumab deruxtecan, has been approved in the EU as a therapy for adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer. These patients are eligible for the drug if they have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment. Enhertu was jointly developed with Daiichi Sankyo, and approval followed a positive recommendation for the therapy from the Committee for Medicinal Products for Human Use. The application was based on results from the Destiny-Breast06 phase 3 trial, in which Enhertu showed a 38% reduction in the risk of disease progression or death compared to chemotherapy. Enhertu was approved in the US earlier this year, with other regulatory applications currently under review in other countries, including Japan. AstraZeneca is now due to make a $125 million milestone payment to Daiichi Sankyo as a result of the approval. The pharmaceutical firm also on Friday received EU approval for Imfinzi, or durvalumab, in combination with chemotherapy as a treatment for adults with resectable non-small cell lung cancer. The treatment is approved for patients with a high risk of recurrence and no epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. A planned interim analysis of event-free survival demonstrated a 32% reduction in the risk of recurrence, progression events or deaths with Imfinzi, versus chemotherapy alone. Imfinzi is currently approved in the US, China and other countries based on results from the Aegean study. Regulatory applications are also under review in other countries including Japan. Executive Vice President Dave Fredrickson said: ‘Today’s approval marks an important step towards improving outcomes for patients in Europe with resectable non-small cell lung cancer, enabling more patients to access this important immunotherapy-based regimen. This new indication builds on the established role of Imfinzi in unresectable disease and underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.’ Shares in AstraZeneca were down 1.2% at £112.54 in London on Friday morning. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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