FDA expands drug to treat NSCLC

FDA has extended approval of crizotinib (Xalkori, Pfizer) for the treatment of certain patients with non-small cell lung cancer (NSCLC).

The wholesale acquisition cost for 1 month of twice-daily therapy with Xalkori for NSCLC is $16,966.70.

According to the National Cancer Institute, lung cancer is the leading cause of cancer-related deaths in the United States, with an estimated 221,000 new diagnoses and 158,040 deaths in 2015. ROS-1 gene alterations, which are thought to lead to cancer-cell growth, are present in approximately 1% of patients with NSCLC.

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Xalkori is an antineoplastic agent known as a kinase inhibitor that blocks the activity of the ROS-1 protein in tumors that have ROS-1 gene alterations. By blocking this activity, Xalkori may prevent NSCLC from growing and spreading.

With the newest FDA approval, Xalkori is now indicated to treat people with metastatic NSCLC whose tumors have an ROS-1 gene alteration.

Xalkori was originally approved in 2011 for the treatment of NSCLC with anaplastic lymphoma kinase (ALK) gene alterations. According to the FDA, the patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLS with ALK gene alterations. 

“The approval of crizotinib for metastatic ROS1-positive non-small cell lung cancer represents another significant step forward in biomarker-driven cancer care,” Alice Shaw, associate professor of medicine at Massachusetts General Hospital and Harvard Medical School, and principal study investigator. “As with ALK-positive lung cancer, ROS1-positive lung cancer defines a distinct subset of patients for whom crizotinib is efficacious.”

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The safety and efficacy of Xalkori were demonstrated in a multicenter, single-arm study of 50 patients with ROS-1 positive metastatic NSCLC. In the study, patients received 250 mg of Xalkori twice daily to measure the drug’s effect on the tumors. Results showed 66% of patients experienced a complete or partial shrinkage of their NSCLC tumors, an effect that lasted a median of 18.3 months.

The safety profile of Xalkori in ROS-1-positive metastatic NSCLC was generally consistent with that observed in patients with ALK-positive metastatic NSCLC. The most common side effects associated with the use of Xalkori include vision problems, nausea, diarrhea, vomiting, edema, constipation, and elevated liver enzymes. Xalkori may also cause more serious side effects, such as life-threatening inflammation of the lungs and abnormal heartbeats. 

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