GSK receives FDA approval for ROS1 inhibitor Jideytro, marking its first lung cancer drug

GSK's FDA approval of Jideytro, a ROS1 inhibitor for advanced non-small cell lung cancer patients with ROS1 gene fusions who have already received ROS1-directed therapy, was announced on Wednesday.

The drug marks GSK's first entry into the lung cancer market and follows the company's $10.6 billion purchase of Nuvalent Bio, which closed last week.

The acquisition also gave GSK the ALK blocker neladalkib, now under FDA review with a decision expected by Nov 27, and both agents are described as having multi-blockbuster potential.

The approval provides a rapid return on the Nuvalent investment and adds to GSK's growing late-stage oncology pipeline.