USFDA Approves GSK's Cancer Drug Jideytro After USD 10.6 Billion Nuvalent Deal
London: GSK said on Wednesday the U.S. FDA approved its drug to treat a form of lung cancer, nearly two months after the British drugmaker acquired the treatment as part of a historic USD 10.6 billion deal.
The approval, which marks GSK's entry into a lucrative market for lung cancer treatment, comes earlier than the FDA's target action date of September 18.
It accelerates GSK's rebuild of a cancer drug business under new CEO Luke Miels, who took over in January and is tasked with leading the company to its ambitious target of over £40 billion in annual sales by 2031.
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."
