WASHINGTON, D.C.: In a milestone for targeted cancer treatments, U.S. regulators have approved Datroway, a precision lung cancer drug developed by AstraZeneca and Japan's Daiichi Sankyo.

This therapy's approval marks the first in lung cancer and significantly broadens access to patients in need of advanced care.

The U.S. Food and Drug Administration approved Datroway to treat a specific type of non-small cell lung cancer (NSCLC) in adults who have already undergone prior treatment, AstraZeneca announced on June 23. The U.S. is the world's largest pharmaceutical market, making this a key regulatory win for the two companies.

Datroway belongs to a cutting-edge class of therapies known as antibody-drug conjugates (ADCs). These are often described as "guided missiles" for their ability to selectively target cancer cells while minimizing damage to healthy tissue. Datroway works by homing in on the TROP2 protein, which is found on the surface of various cancer cells.

"This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation," said Dave Fredrickson, executive vice president of AstraZeneca's oncology business.

Datroway was already approved for a form of breast cancer, but this is its first nod for use in lung cancer, one of the most aggressive and deadly forms of the disease. Non-small cell lung cancer accounts for the vast majority of lung cancer cases.

The approval is based on clinical data showing that Datroway can deliver effective results in patients whose disease has progressed after other treatments. It offers hope to those who may have few remaining options and could reshape treatment approaches for specific lung cancer subtypes.

AstraZeneca and Daiichi Sankyo have been partners in cancer drug development since they launched Enhertu, another ADC, and later expanded their collaboration in 2020 with a deal to develop and commercialize Datroway. That agreement is valued at up to US$6 billion.

Following the FDA's green light, AstraZeneca will pay Daiichi Sankyo $45 million in milestone-related payments, the company said on June 23.