FDA Approves NSCLC Treatment Acquired by GSK in Nuvalent Deal

Editor’s Take: The treatment was key to GSK’s acquisition of Nuvalent, now becoming GSK’s first approved medicine in lung cancer.

The U.S. FDA approved GSK’s Jideytro (zidesamtinib) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The approval applies to adult patients who received a prior ROS1 kinase inhibitor; similarly, Jideytro targets the ROS1 gene.

GSK picked up Jideytro as part of the portfolio of Nuvalent, whose pending acquisition GSK announced in June. At the time, GSK said it would be paying $10.6 billion in the deal. Also by that point, zidesamtinib as well as neladalkib gained FDA Breakthrough Therapy and Orphan Drug designations in NSCLC.

Milestone for GSK

Jideytro now becomes GSK’s first approved medicine in lung cancer, as Chief Scientific Officer Tony Wood elucidated.

“The rapid progression of Jideytro from development to approval reflects the strength of the underlying science,” Wood said.

Wood also commented on an “urgent need for additional effective and tolerable treatments” for this type of lung cancer.

“[The] approval provides an important new option for these patients,” Wood said. “[It] supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care.”

Unmet Need in NSCLC Treatment

According to GSK, approximately 50,000 people globally receive a ROS1-positive NSCLC diagnosis. Among those often diagnosed are non-smokers in their 40s and 50s. GSK says these patients may remain on treatment for several years.

The FDA approved Jideytro based on results from a global, single-arm Phase I/II clinical trial (ARROS-1). This trial demonstrated meaningful, durable responses, particularly in patients with brain metastases and ROS1 resistance mutations.

GSK says it will continue to advance other medicines from the Nuvalent acquisition. This includes neladalkib, which has an FDA target decision date of Nov. 27, 2026.