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The FDA has approved zidesamtinib (Jideytro, GSK) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The ROS1 kinase inhibitor was specifically approved for those who previously received another drug of the same class, according to a press release from GSK. Zidesamtinib “was designed as a ROS1 selective inhibitor with broad coverage of ROS1 resistance mutations, activity against disease that has spread to the brain, durable treatment responses and a tolerable profile.”
The approval was based on the results from 117 patients with ROS1-positive NSCLC previously treated with a ROS1 inhibitor from the global single-arm ARROS-1 phase 1/2 clinical trial. The ARROS-1 trial evaluated the new agent in patients with advanced ROS1 positive NSCLC and other ROS1-positive solid tumors. In the population with NSCLC, the objective response rate was 44%, and the duration of response rates at 6 and 12 months were 82% and 69%, respectively.
“The study demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations,” according to the GSK statement.
Investigators are studying whether zidesamtinib can also be used as first-line treatment for patients in the ARROS-1 trial.
The most common adverse reactions in the pooled safety population of 446 patients included oedema, peripheral neuropathy, constipation, fatigue, and dyspnea.
The US Prescribing Information will be available at fda.gov/drugs.
