Daiichi Sankyo and AstraZeneca have withdrawn their EU marketing authorization application for datopotamab deruxtecan (Dato-DXd) in locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This decision follows feedback from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is based on data from the TROPION-Lung01 phase 3 trial. While the companies will continue developing datopotamab deruxtecan for lung cancer with ongoing clinical trials, this withdrawal impacts their strategy for bringing this drug to the European market.
This withdrawal represents a setback for patients with advanced NSCLC who lack effective treatment options after progressing on standard therapies like chemotherapy, immunotherapy, and targeted treatments. The potential of a TROP2-directed antibody-drug conjugate like datopotamab deruxtecan offered a new mechanism of action and a possible new therapeutic avenue, highlighting the unmet need in this patient population. The withdrawal underscores the challenges in drug development and the rigorous standards required for regulatory approval in the EU.
The withdrawal specifically affects the lung cancer application based on the TROPION-Lung01 trial, where datopotamab deruxtecan was compared to docetaxel in patients previously treated with other therapies. The trial measured progression-free survival and overall survival as primary endpoints. It’s important to note that another application for datopotamab deruxtecan, for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer, is still under review by the EMA. Globally, lung cancer remains a significant health concern with nearly 2.5 million diagnoses in 2022 and almost 500,000 in Europe alone.
This withdrawal likely necessitates a reassessment of the clinical development strategy for datopotamab deruxtecan in lung cancer within the EU. While the companies have expressed continued commitment to the drug’s development, the specific path forward remains unclear. They will need to address the concerns raised by the CHMP, potentially through additional clinical trials or data analyses. This situation highlights the complexities of bringing novel cancer therapies to market and the importance of robust clinical data to demonstrate clear benefit for patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
