AstraZeneca’s Datroway Gains U.S. Approval for Lung Cancer Treatment

AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo have secured FDA approval for Datroway, their antibody-drug conjugate (ADC), to treat advanced non-small cell lung cancer (NSCLC) in patients following prior therapy. This marks the drug's first U.S. indication beyond breast cancer, expanding options for patients with TROP2-expressing tumors.

Datroway—often described as a “guided missile” therapy—binds to the TROP2 protein on malignant cells, delivering a cytotoxic payload directly to tumors while minimizing damage to healthy tissue. The approval addresses a critical need for patients with EGFR-mutated NSCLC who have exhausted existing treatments.

Key Highlights:

• First U.S. NSCLC ADC: Datroway becomes the inaugural TROP2-targeted ADC approved for lung cancer.

• Mechanism of Action: Targets TROP2 to deliver potent chemotherapy selectively, improving the therapeutic window versus standard regimens.

• Broad Resistance Coverage: Indicated regardless of specific resistance mutations, making it a versatile option post-EGFR inhibitor failure.

Track AstraZeneca's credit rating and debt metrics via the Company Rating & Information API company-rating to assess financial stability as it scales Datroway commercialization.

AstraZeneca and Daiichi Sankyo's collaboration, initiated with Enhertu in breast cancer and expanded under a $6 billion 2020 agreement, now extends to lung oncology. The lung-cancer approval is based on positive Phase II/III trial results showing meaningful progression-free survival and response rates.

View AstraZeneca's revenue breakdown and R&D spend supporting Datroway through the Full Financial Statements API full-financial-statement-as-reported.

Datroway's launch is set to reshape NSCLC treatment paradigms, offering a precision therapy that addresses resistance mechanisms and enhances patient outcomes in a high-unmet-need population.