Just days after completing a $10.6bn takeover of lung cancer biotech Nuvalent, GSK is already reaping the rewards with Jideytro (zidesamtinib) having gained US approval in ROS1-positive non-small cell lung cancer (NSCLC).
This means the selective ROS1 kinase inhibitor is now indicated for use in American adults with locally advanced or metastatic ROS1-positive NSCLC, provided they have already previously received treatment with a prior ROS1 kinase inhibitor. This is GSK’s first drug for lung cancer to make it to market.
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The US Food and Drug Administration (FDA) opted to approve Jideytro based on the results of the single-arm Phase I/II ARROS-1 study (NCT05118789), in which the drug triggered an objective response rate (ORR) of 44% in the overall patient population, which included patients with brain metastases and ROS1 resistance mutations.
GSK acquired the rights to Jideytro and fellow late-stage lung cancer candidate through its multi-billion-dollar acquisition of Massachusetts-based biotech, Nuvalent, which closed on 15 July 2026.
According to the British pharma company, Jideytro has been specifically designed to overcome the challenges linked to approved therapies in this indication – including the acquisition of ROS1 resistance mutations following treatment, as well as inefficient blood-brain barrier penetration for patients with brain metastases.
Jideytro will now join Pfizer’s ROS1-positive NSCLC therapy, Lorbrena (lorlatinib), on the market, which achieved blockbuster status in 2025. Currently, analysts from GlobalData estimate that Lorbrena sales will increase at a compound annual growth rate of 8.3% between 2025 and 2032.
Nuvalent acquisition fuels GSK growth
As GSK makes its first foray into the lung cancer space, it is also betting on the potential of other candidates from the Nuvalent acquisition that could bolster its positioning in the space. This includes neladalkib, an ALK-selective tyrosine kinase inhibitor, which is currently under review by the US Food and Drug Administration (FDA), with the agency expected to make a call on the drug’s market future on 27 November 2026.
Another less developed asset GSK acquired from the Nuvalent acquisition was HER2-altered NSCLC candidate, NVL-330, which is currently being evaluated in a Phase I trial.
In a previous research note, Jefferies analysts noted that the Nuvalent acquisition adds “highly profitable” assets with a long duration of therapy plus an ability to move up the treatment cascade. They add that these assets also carry “meaningful revenue potential into the post-2030 period”.
This comes as the company contends with key upcoming patent expiries within its HIV medicines portfolio – including Tivicay (dolutegravir), which is expected to lose its market exclusivity in 2028.
