AstraZeneca and Daiichi Sankyo said the European Commission has approved Enhertu (trastuzumab deruxtecan) in the European Union as the first tumor-agnostic HER2-directed therapy and antibody-drug conjugate for patients with previously treated HER2-positive metastatic solid tumors. The authorization covers adult patients whose tumors are HER2‑positive, who have received prior systemic therapy and who have no satisfactory alternative treatment options, following a positive opinion from the Committee for Medicinal Products for Human Use.
According to the companies, the decision is based on results from the DESTINY‑PanTumour02, DESTINY‑Lung01 and DESTINY‑CRC02 trials, along with data from a phase 2 non‑randomized dose‑finding study and a non‑comparative arm in patients with non‑small cell lung cancer in DESTINY‑Lung02. These studies evaluated Enhertu in HER2‑positive metastatic solid tumours across multiple cancer types, including endometrial, cervical, ovarian, bladder and biliary tract cancers, as well as non‑small cell lung cancer and colorectal cancer, in patients who had previously received systemic therapy.
The new approval adds a tumor‑agnostic indication to Enhertu’s existing EU authorizations in breast, lung and gastric cancers. Under the updated label, Enhertu can be used as monotherapy in eligible patients regardless of the site of the original solid tumor, provided it is HER2‑positive and meets the criteria for prior treatment and lack of suitable alternatives.
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