The U.S. FDA has approved GSK's lung cancer drug, Jideytro, for a rare subtype of the disease. The approval, which came nearly two months early, marks GSK's entry into the lucrative lung cancer market and is a key part of new CEO Luke Miels' strategy. The drug was acquired as part of a $10.6 billion deal for a treatment developed by Nuvalent and showed a 44% tumor response rate in clinical trials.
FDA approval for Jideytro
- ▪The U.S. FDA approved GSK's lung cancer drug Jideytro on July 22, 2026, ahead of its September 18 target date
- ▪Jideytro is approved for previously treated patients with ROS1-positive non-small cell lung cancer, a rare subtype
- ▪A GSK spokesperson said Jideytro will be available in pharmacies in the coming weeks
- ▪The ROS1-positive subtype is driven by an altered ROS1 protein that fuels cancer growth and spread
Nuvalent acquisition deal
- ▪The drug was developed by U.S. biotech Nuvalent, which GSK acquired in June 2026
- ▪The FDA is expected to make a decision on Nuvalent's second lung cancer drug, neladalkib, by November 2026
- ▪GSK acquired the treatment as part of a $10.6 billion deal
GSK oncology strategy
- ▪The approval marks GSK's entry into the lucrative lung cancer treatment market
- ▪The approval accelerates GSK's rebuild of its cancer drug business under new CEO Luke Miels, who took over in January 2026
- ▪GSK is targeting over £40 billion in annual sales by 2031
Clinical trial results
- ▪Among patients who responded to the treatment, 82% were still responding at six months and 69% at 12 months
- ▪Jideytro's approval was based on data from an early- to mid-stage trial involving patients previously treated with ROS1-targeted medicines
- ▪In the trial, 44% of 117 patients had their tumors shrink or disappear
Competitive lung cancer market
- ▪Jideytro will compete with Bristol Myers Squibb's Augtyro, Roche's Rozlytrek, and Pfizer's Xalkori
- ▪The lung cancer drug market is one of the largest segments of the global oncology market, with billions in annual sales
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