AstraZeneca and Daiichi Sankyo have achieved a significant milestone by securing FDA approval for Datroway, an innovative antibody-drug conjugate (ADC), designed for treating advanced non-small cell lung cancer (NSCLC) in patients after prior therapy. This approval marks Datroway’s first U.S. recognition for use beyond breast cancer, thereby expanding treatment options for patients with TROP2-expressing tumors.

Often referred to as a guided missile therapy, Datroway selectively binds to the TROP2 protein found on malignant cells, delivering targeted cytotoxic treatment and minimizing harm to healthy tissues. This therapy tackles a critical unmet need for patients suffering from EGFR-mutated NSCLC who have run out of available treatment options.

Key Highlights:

• First U.S. NSCLC ADC: Datroway stands as the first TROP2-targeted ADC to gain approval for lung cancer treatment.
• Mechanism of Action: The drug specifically targets TROP2, providing potent chemotherapy that improves therapeutic outcomes compared to standard treatment protocols.
• Broad Resistance Coverage: Datroway is indicated for patients with various resistance mutations, thereby establishing its role as a versatile treatment post-EGFR inhibitor failure.

The partnership between AstraZeneca and Daiichi Sankyo, which began with Enhertu in breast cancer under a $6 billion agreement in 2020, is further solidified through its recent focus on lung cancer therapies. The lung cancer approval is based on promising Phase II/III trial results that demonstrate significant progression-free survival rates as well as response rates.

The launch of Datroway is poised to reform the landscape of NSCLC treatment by introducing a precision therapy that addresses resistance mechanisms and ultimately enhances patient outcomes in a population with substantial unmet medical needs.