FDA Grants Priority Review to Datopotamab Deruxtecan for Advanced EGFR+ Lung Cancer

Datopotamab deruxtecan (Dato-DXd) has been granted Priority Review from the US FDA for advanced EGFR-mutated non-small cell lung cancer (NSCLC) following prior therapies. AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) is supported by data from the TROPION-Lung05 Phase II trial, TROPION-Lung01 Phase III trial, and TROPION-PanTumor01 Phase I trial.

Pooled analysis showed a 42.7% objective response rate and a 7-month median duration of response. Datopotamab deruxtecan previously received FDA Breakthrough Therapy Designation and showed a consistent safety profile with no new concerns. Approval would mark its first indication in lung cancer, enhancing treatment for this patient population.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Acquired resistance to front-line therapies and, ultimately, disease progression are unfortunate realities for most patients with advanced EGFR-mutated non-small cell lung cancer. This Priority Review, and the previously granted Breakthrough Therapy Designation, recognise the potential for datopotamab deruxtecan to provide a much-needed option to patients whose disease has become resistant to current treatments.”  

AstraZeneca and Daiichi Sankyo are evaluating datopotamab deruxtecan alone and in novel combinations as treatment for patients with NSCLC in seven Phase III trials including the TROPION-Lung14 and TROPION-Lung15 trials of datopotamab deruxtecan alone and with Tagrisso (osimertinib) as treatment for patients with advanced or metastatic EGFRm nonsquamous NSCLC.

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “Treating advanced EGFR-mutated non-small cell lung cancer presents a significant challenge due to the limited efficacy of available treatments once the disease has progressed following front-line therapies, including the use of an EGFR-tyrosine kinase inhibitor. If approved, datopotamab deruxtecan could become the first TROP2-directed antibody drug conjugate for lung cancer, providing a promising option for patients.”