GSK receives FDA approval for Jideytro lung cancer drug
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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