FDA Approves Zidesamtinib, New Treatment for ROS1-Mutant Lung Cancer

The U.S. Food and Drug Administration (FDA) approved on July 22, 2026, the drug zidesamtinib, marketed as Jideytro by GSK, to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with ROS1 mutations in patients previously treated with another ROS1 inhibitor.

A second-line treatment with notable results in the clinical trial

The recommended dose is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity occurs. The approval was supported by a clinical study with 117 patients: 59 of them had previously received a single ROS1 inhibitor and achieved an objective response rate of 49%, while the remaining 58, who had already received two or more prior inhibitors, recorded a response rate of 38%.

The drug also showed relevant activity against brain metastases, an aspect considered key because this type of cancer frequently spreads to the brain. The zidesamtinib prescribing information includes warnings about central nervous system adverse reactions, QTc interval prolongation, interstitial lung disease or pneumonitis, bone fractures, myalgia with elevated creatine phosphokinase, pancreatic toxicity, and embryofetal toxicity.

Approval came ahead of schedule

The FDA’s green light came before the original deadline of September 18, 2026, under the Breakthrough Therapy and Orphan Drug designations that the agency had already granted to the drug. With this approval, zidesamtinib becomes a second-line option for a group of patients with ROS1-positive lung cancer who, after progressing on prior targeted therapies, had historically limited treatment alternatives.