AstraZeneca's Datroway gains FDA approval for treating advanced non-small cell lung cancer

From Financial Modeling Prep: 2025-06-24 07:24:00

AstraZeneca and Daiichi Sankyo gain FDA approval for Datroway, an antibody-drug conjugate, to treat advanced non-small cell lung cancer post-prior therapy, marking its first U.S. indication beyond breast cancer. The drug targets TROP2-expressing tumors, offering a guided missile therapy that delivers cytotoxic payload directly to tumors while sparing healthy tissue.

Datroway, the first TROP2-targeted ADC for lung cancer in the U.S., binds to TROP2 protein on malignant cells to deliver potent chemotherapy selectively, providing a versatile option post-EGFR inhibitor failure. The approval addresses a critical need for patients with EGFR-mutated NSCLC who have exhausted existing treatments.

AstraZeneca and Daiichi Sankyo’s collaboration expands to lung oncology with Datroway’s approval for NSCLC, following positive Phase II/III trial results. The drug’s launch is poised to reshape NSCLC treatment paradigms by offering a precision therapy that addresses resistance mechanisms and improves patient outcomes in a high-unmet-need population.



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