GSK secures FDA approval for lung-cancer drug Jideytro after $10.6 billion Nuvalent acquisition

GSK received FDA clearance for Jideytro, a therapy for patients with metastatic non‑small cell lung cancer that have ROS1 gene alterations and have already been treated with another targeted drug.

The approval was granted ahead of the September 18 deadline, building on breakthrough therapy and orphan drug designations that speeded the review process.

The decision follows GSK’s $10.6 billion purchase of Nuvalent last week, the company’s largest acquisition in eight years, which added Jideytro and another candidate, neladalkib, to its pipeline.

This marks GSK’s first FDA approval for a lung‑cancer medicine and signals the firm’s broader strategy to expand its oncology portfolio beyond its traditional HIV, respiratory and vaccine businesses.