What's Happening?
Daiichi Sankyo and AstraZeneca have filed for European Union approval of their drug Datroway (dapotamab deruxtecan) for the treatment of triple-negative breast cancer (TNBC). This application follows the release
of positive survival data from the TROPION-Breast02 trial, which demonstrated that Datroway significantly improves overall survival compared to chemotherapy in patients with advanced TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. TNBC is a particularly aggressive form of breast cancer, representing 15% of all cases and characterized by a poor prognosis. The trial results showed that Datroway achieved a median progression-free survival of 10.8 months, a 43% improvement over chemotherapy, and a 21% better overall survival rate. Datroway is already approved for other cancer types, including metastatic HR-positive, HER2-negative breast cancer, and advanced EGFR-mutated non-small cell lung cancer.
Why It's Important?
The approval of Datroway in the EU could provide a significant new treatment option for patients with TNBC, a group that currently faces limited therapeutic choices and poor outcomes. The drug's ability to improve survival rates over traditional chemotherapy could change the standard of care for this aggressive cancer type. This development is particularly crucial as approximately 70% of metastatic TNBC patients are not eligible for existing immunotherapies due to the absence of the PD-L1 biomarker. The competition between Datroway and Gilead Sciences' Trodelvy, another TROP2-targeting drug, highlights the ongoing efforts to improve treatment options for TNBC. The success of Datroway could also have financial implications for Daiichi Sankyo and AstraZeneca, with potential peak sales projected at $5 billion.
What's Next?
Following the EU filing, Daiichi Sankyo and AstraZeneca plan to pursue additional regulatory approvals for Datroway in other markets. The companies are likely to continue their efforts to expand the drug's indications and improve its market presence. The ongoing competition with Gilead Sciences' Trodelvy will also be a focal point, as both drugs aim to establish themselves as the preferred treatment for TNBC. The outcome of these regulatory processes and market dynamics will be closely watched by stakeholders in the pharmaceutical industry and the oncology community.
