AstraZeneca and Daiichi Sankyo have announced a resubmission of their application to the U.S. Food and Drug Administration (FDA) for datopotamab deruxtecan (Dato-DXd) in a specific form of lung cancer. This strategic move will delay the drug's market entry and raises questions about its potential widespread use.
Dato-DXd, an antibody-drug conjugate (ADC), represents a next-generation chemotherapy approach. AstraZeneca, in partnership with Daiichi Sankyo, views Dato-DXd as a critical component in achieving its ambitious financial goals, aiming to nearly double its revenue to $80 billion by 2030.
The initial FDA submission for Dato-DXd in February targeted advanced nonsquamous non-small cell lung cancer (NSCLC), leveraging results from the Tropion-Lung01 trial. The companies have also filed for approval in a form of breast cancer. However, comprehensive trial data released in September revealed that Dato-DXd did not demonstrate superior overall survival compared to standard chemotherapy regimens.
The full data set of the Tropion-Lung01 trial, which was a randomized, open-label, Phase 3 study, involved patients with advanced or metastatic NSCLC who had progressed following prior systemic therapy. The primary endpoint was progression-free survival, while overall survival was a key secondary endpoint. While Dato-DXd showed an improvement in progression-free survival, the overall survival data did not reach statistical significance, impacting the regulatory path forward.
This resubmission reflects a strategic recalibration based on the complete data analysis and ongoing discussions with regulatory authorities. The companies remain committed to developing Dato-DXd for various cancer indications, but the revised approach underscores the complexities and challenges inherent in oncology drug development.
