GlaxoSmithKline (GSK) has received approval from the US Food and Drug Administration (FDA) for a new cancer treatment called Jideytro (scientific name: zidesamtinib). This medicine is for adults with advanced or spreading ROS1-positive non-small cell lung cancer who have already been treated with a ROS1-targeted drug. The FDA gave the approval earlier than expected, on the basis of its Breakthrough Therapy and Orphan Drug designations.
Jideytro was developed by GSK through its purchase of Nuvalent, a biotechnology company. It was designed to overcome two main challenges in treating ROS1-positive lung cancer: ensuring the medicine works effectively and is tolerated well by patients. Its advanced design allows it to target ROS1 mutations precisely, cover common resistance mutations, and reach the brain, where cancer may spread.
Each year, around 50,000 people worldwide are diagnosed with ROS1-positive lung cancer. This type of cancer often affects people who have never smoked, typically in middle age, and patients may need treatment for several years.
Tony Wood, the Chief Scientific Officer at GSK, stated: “The swift approval of Jideytro shows how strong the science behind it is and how badly new, effective, and well-tolerated treatments are needed for ROS1-positive lung cancer patients.”
He added: “This approval gives patients a new and important treatment option and supports our plan to invest in medicines that could significantly improve how we care for people with cancer.”
The approval of Jideytro is based on results from a global clinical trial called ARROS-1. This study involved patients who had already been treated with a ROS1 inhibitor. It showed that Jideytro produced meaningful and lasting responses, including in patients whose cancer had spread to the brain or developed resistance to previous treatments.
In the study, which included 117 patients, 44% experienced tumor shrinkage or disappearance. At six months, 82% of patients who responded kept responding, and at twelve months, 69% did.
Dr. Alexander Drilon, who led the ARROS-1 trial, said: “Even though we’ve made progress, resistance to treatment, spread to the brain, and side effects still make life difficult for patients. The results from ARROS-1, especially in patients who had already received several treatments, show real progress in the fight against this disease.”
Janet Freeman-Daily, Co-Founder and President of The ROS1ders, a patient advocacy group, commented: “For patients, the goal isn’t just to live longer but to live better while on treatment. This approval provides patients and their doctors with a new and important option and marks meaningful progress for our community.”
GSK is also developing other targeted lung cancer treatments from the Nuvalent acquisition, including neladalkib for ALK-altered lung cancer, NVL-330 for HER2-altered lung cancer, and risvutatug rezetecan, which is in late-stage development.