The Food and Drug Administration has approved GSK’s ROS1 inhibitor zidesamtinib, branded as Jideytro, for certain types of lung cancer, according to a July 23 announcement. The approval covers patients with advanced non-small cell lung cancer who are positive for the ROS1 gene fusion and have previously received ROS1-directed therapy.
This regulatory decision marks GSK’s entry into the lung cancer market following its $10.6 billion acquisition of Nuvalent Bio, which was announced in June and closed last week. In addition to zidesamtinib, the acquisition brought GSK the ALK blocker neladalkib, which is currently under FDA review for non-small cell lung cancer, with an approval decision expected by Nov. 27.
GSK said in its news release announcing the Nuvalent deal that both Jideytro and neladalkib have “multi-blockbuster potential.” The company added that around 50,000 people globally are diagnosed with ROS1-positive non-small cell lung cancer each year, many of whom are non-smokers in middle age “who could stay on treatment for several years.”
Jideytro’s approval was supported by data from the Phase 1/2 single-arm ARROS-1 clinical trial showing an overall response rate of 44%. Duration of response rates were reported at 82% at six months and 69% at twelve months. According to GSK, the drug showed “meaningful and durable responses,” even in patients with brain metastases and resistance mutations related to ROS1.
Beyond Jideytro and neladalkib, GSK also gained NVL-330 through its purchase of Nuvalent Bio. This candidate is being studied in early-stage development for HER2-altered non-small cell lung cancer. Enrollment is ongoing for a Phase 1a/1b study listed on a federal trials database.
The newly acquired assets join risvutatug rezetecan (ris-rez), an antibody-drug conjugate developed in partnership with Hansoh Pharmaceutical. Recent data from a Phase 3 trial showed improved survival outcomes compared to standard care among patients treated with ris-rez. Hansoh plans to seek regulatory approval for ris-rez in China.
