AstraZeneca, in partnership with Japan's Daiichi Sankyo, has received approval from U.S. regulators for its precision oncology drug Datroway to treat a specific form of lung cancer. This marks the first U.S. approval for Datroway in this indication, expanding treatment options for patients with advanced non-small cell lung cancer (NSCLC).
Announced on Tuesday, AstraZeneca confirmed that Datroway is now approved in the U.S. — the world’s largest pharmaceutical market — for use in adults with advanced NSCLC who have previously undergone treatment. This approval makes Datroway the first therapy of its kind cleared by the U.S. Food and Drug Administration (FDA) for this patient group.
Datroway is part of a class of cutting-edge therapies known as antibody-drug conjugates (ADCs) — often described as "guided missiles" — that precisely target cancer cells while sparing healthy tissues, minimizing side effects commonly associated with traditional chemotherapy. The drug works by targeting the TROP2 protein, which is present on the surface of tumor cells in various cancers. Datroway is already approved for treating certain types of breast cancer.
“This first approval of Datroway in lung cancer offers a much-needed option for patients with advanced EGFR-mutated NSCLC whose disease has become resistant to previous treatments, regardless of the underlying mutations driving the disease,” said Dave Fredrickson, Executive Vice President at AstraZeneca.
The approval builds on a long-standing collaboration between AstraZeneca and Daiichi Sankyo, which began with the development of Enhertu and expanded in 2020 with a deal to co-develop and commercialize Datroway. That agreement was valued at up to $6 billion.
Following this latest U.S. regulatory approval, AstraZeneca will pay Daiichi Sankyo $45 million in milestone payments, as part of their collaboration terms.