AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been given Priority Review by the US FDA for the treatment of adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
Priority Review is granted by the FDA to therapies that have the potential to improve on available treatments, either through enhanced safety or efficacy, prevention of serious conditions or improved patient compliance. The sBLA for Datroway is being reviewed under Project Orbis, which helps to accelerate the approval of oncology treatments.
Around 70% of metastatic TNBC patients are not eligible for immunotherapy. In these cases, the only approved first-line treatment is chemotherapy. There is a significant unmet medical need for treatments to fill this gap.
The sBLA for Datroway follows the release of data from the phase 3 TROPION-Breast02 trial. Compared to first-line chemotherapy, Datroway showed a five-month improvement in median overall survival and a 43% reduction in risk of progression or death in immunotherapy-ineligible metastatic TNBC patients. Datroway also showed greater durability of treatment response.
Susan Galbraith, executive vice president, oncology haematology R&D at AstraZeneca, said: “Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population, as demonstrated in the TROPION-Breast02 trial – the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease.
“The Priority Review of our submission underscores the impact of these results, and its review under Project Orbis signals a widely shared commitment to bringing Datroway to patients around the world as quickly as possible.”
The study found that Datroway’s safety profile was consistent with other trials of the treatment in breast cancer indications.
Global regulatory submissions for Datroway in breast and lung cancer indications are ongoing.