Drugs

FDA Approves GSK's Jideytro for ROS1-Positive Lung Cancer

FDA has approved GSK's Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously been treated with a ROS1 kinase inhibitor, giving patients with the rare form of lung cancer a new targeted treatment option. The approval came ahead of the drug’s 9/18 user fee target date and follows the agency’s earlier Breakthrough Therapy and Orphan Drug designations.

Jideytro is GSK's first approved treatment for lung cancer and was added to the company's pipeline through its recent acquisition of Nuvalent Inc. The next-generation ROS1-selective inhibitor was designed to overcome resistance mutations, improve tolerability and penetrate the blood-brain barrier to treat tumors that have spread to the central nervous system.

The approval was supported by data from the global Phase I/II ARROS-1 trial, which enrolled patients with advanced or metastatic ROS1-positive NSCLC who had previously received a ROS1 inhibitor, according to the company.

Among 117 evaluable patients, Jideytro achieved an objective response rate of 44%, with responses proving durable over time. The duration of response rate was 82% at six months and 69% at 12 months. The study also demonstrated activity in patients with brain metastases and ROS1 resistance mutations.

"The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer," GSK's chief scientific officer Tony Wood is quoted in a release as saying.

ROS1-positive NSCLC is a rare molecular subtype of lung cancer diagnosed in an estimated 50,000 people worldwide each year. The disease frequently affects younger adults, including non-smokers in their 40s and 50s, and commonly spreads to the brain.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome