GSK enters lung cancer drug market with early FDA nod for Jideytro
GSK•Trial results and competitive landscape
The drug Jideytro was approved for previously treated patients with ROS1-positive non-small cell lung cancer, a rare subtype driven by an altered ROS1 protein that fuels cancer growth and spread.
The drug will compete with Bristol Myers Squibb's Augtyro, as well as older treatments Roche's Rozlytrek and Pfizer's Xalkori.
Lung cancer is one of the biggest segments of the global oncology market, generating billions of dollars in annual drug sales.
The approval was based on data from an early- to mid-stage trial involving patients previously treated with ROS1-targeted medicines. The trial was conducted by U.S. biotech Nuvalent, which GSK acquired last month.
In the trial, 44% of 117 patients had their tumors shrink or disappear, and among those who responded to the treatment, 82% were still responding at six months and 69% at 12 months.
The FDA is expected to make a decision on Nuvalent's second lung cancer drug, neladalkib, by November.
GSK is also accelerating the development of a third drug, ris-rez, which met its main goal of improving survival in a late-stage trial of patients in China.
A GSK spokesperson told Reuters, "We are working to ensure patients have access to Jideytro as soon as possible with medicine available in pharmacies in the coming weeks."
