GSK has received US Food and Drug Administration (FDA) approval for Jideytro (zidesamtinib), a targeted therapy for patients with ROS1-positive non-small cell lung cancer (NSCLC), just days after completing its USD 10.6 billion acquisition of Nuvalent.

The approval marks GSK's entry into the lung cancer market, with Jideytro becoming the company's first commercially available treatment for the disease. 

The drug is indicated for adults in the US with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with another ROS1 kinase inhibitor.

The FDA's decision was based on data from the Phase I/II ARROS-1 trial, in which Jideytro demonstrated an objective response rate (ORR) of 44% among patients, including those with brain metastases and ROS1 resistance mutations.

GSK gained the rights to Jideytro through its acquisition of Massachusetts-based biotech Nuvalent, a transaction that closed on July 15, 2026. The acquisition also added a pipeline of precision oncology assets aimed at strengthening GSK's long-term position in lung cancer.

According to GSK, Jideytro was specifically designed to address key limitations of existing ROS1-targeted therapies, including treatment resistance caused by ROS1 mutations and inadequate penetration of the blood-brain barrier in patients with brain metastases.

The approval positions Jideytro alongside Pfizer's Lorbrena (lorlatinib), currently a leading therapy for ROS1-positive NSCLC. Lorbrena achieved blockbuster status in 2025, with market analysts projecting continued sales growth over the coming years.

Beyond Jideytro, GSK is advancing additional oncology candidates acquired through the Nuvalent deal. These include neladalkib, an ALK-selective tyrosine kinase inhibitor currently under FDA review, with a regulatory decision expected by November 27, 2026, and NVL-330, an investigational therapy targeting HER2-altered NSCLC that is being evaluated in a Phase I clinical trial.