A new oral medication has been approved to treat a rare form of advanced lung cancer, offering fresh hope to patients with a particularly aggressive subtype of non-small-cell lung cancer (NSCLC). The drug, known as taletrectinib and sold under the brand name Ibtrozi, is designed specifically for adults with ROS1-positive NSCLC that has spread or worsened.
NSCLC is the most prevalent form of lung cancer and a major contributor to cancer-related deaths globally. Around 2% of advanced NSCLC cases involve ROS1 gene mutations, which typically make the disease more aggressive and difficult to treat. Unlike other types of lung cancer, ROS1-positive NSCLC often occurs in younger patients many of whom have no history of smoking. One of the major challenges in treating this form of cancer is its tendency to spread to the brain, affecting over one-third of patients at diagnosis and nearly half after treatment begins.
Ibtrozi addresses this challenge by targeting the faulty ROS1 protein, slowing tumor growth and helping prevent further spread, especially to the brain. The once-daily pill belongs to a class of medicines known as tyrosine kinase inhibitors (TKIs). These therapies block cancer-driving signals at a cellular level. Ibtrozi is engineered to effectively penetrate the brain, helping to maintain control of the disease even when it metastasizes.
The FDA’s approval was based on the outcomes of two separate clinical trials. One included 113 participants who had previously been treated with similar drugs, while the other involved 157 people who had not received such treatment. The results were promising. Among those new to targeted therapy, 85% to 90% responded to Ibtrozi, and at least 63% experienced lasting benefits for more than a year. Even among patients who had already undergone similar treatments, 52% to 62% showed improvement, with up to 83% continuing to respond for at least six months.
Notably, the drug showed strong results in shrinking brain tumors, a major concern in this cancer type. Among patients who had not received earlier treatment, 73% saw a reduction in brain tumors. Those previously treated experienced a 63% response rate.
The recommended dosage is 600 mg taken once daily on an empty stomach, with no food for at least two hours before and after taking the pill. Treatment continues until the cancer progresses or side effects become unmanageable.
Common side effects include nausea, fatigue, diarrhea, and dizziness. More serious risks involve liver toxicity, lung inflammation, heart rhythm disturbances, and potential harm to unborn babies. Patients are advised to discuss all medications they are taking with their doctor and to avoid sun exposure during and shortly after treatment. Women should not breastfeed while using the drug and for three weeks after stopping it.
