AstraZeneca-Daiichi Sankyo application for Datopotamab deruxtecan accepted in US for patients with previously treated advanced nonsquamous non-small cell lung cancer

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

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy. With regulatory discussions ongoing around the world and a parallel submission underway in the US in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible.”

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “This news is an important step forward in our goal of creating new standards of care that have the potential to transform the treatment of patients with non-small cell lung cancer. We are encouraged by the FDA’s acceptance of the BLA as we endeavour to make datopotamab deruxtecan the first TROP2-directed antibody drug conjugate approved to treat patients with nonsquamous non-small cell lung cancer after disease progression on prior systemic therapy. We look forward to working closely with the FDA to bring datopotamab deruxtecan to patients.”

Results from TROPION-Lung01 were presented during a Presidential Symposium at the 2023 European Society for Medical Oncology Congress.

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

A parallel BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Breast01 Phase III trial is pending acceptance in the US for the treatment of adult patients with metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.