FDA OKs Xalkori (Crizotinib) for Rare Type of Advanced Lung Cancer

The US Food and Drug Administration (FDA) has approved the first treatment for people with advanced, ROS1-positive non-small cell lung cancer. These tumors have a mutation in the ROS1 gene that affects only about 1% of people with non-small cell lung cancer. Many people with this type of lung cancer tend to be younger than the average lung cancer patient and are less likely to have been smokers.

The drug, Xalkori (crizotinib), was previously approved for patients with advanced non-small cell lung cancer that has a mutation in a gene called ALK. It’s a targeted therapy that works by blocking the changes in the lung cancer cells that help them grow.

The FDA based its latest approval of Xalkori on a study of 50 people with ROS1-positive non-small cell lung cancer that had spread beyond the original location of the tumor. Results showed 2/3 of participants (66%) saw their tumors shrink or disappear. The improvement lasted an average 18.3 months.

Xalkori was approved using 2 FDA programs – breakthrough therapy designation and priority review status – designed to speed up the availability of drugs to treat serious diseases. It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

Xalkori is taken as a pill. The most common side effects are vision problems, nausea and vomiting, diarrhea, swelling, constipation, liver problems, fatigue, decreased appetite, upper respiratory infection, and dizziness and numbness or tingling in the hands or feet (neuropathy). Less common, but more serious side effects are possible, including severe liver problems, life-threatening or fatal inflammation of the lungs, abnormal heartbeats and partial or complete loss of vision in one or both eyes.

Xalkori is marketed by Pfizer.

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