FDA Approves Xalkori Capsules for Metastatic Non-Small Cell Lung Cancer

The FDA today approved crizotinib (Xalkori) capsules for patients with metastatic non-small cell lung cancer (NSCLC) and ROS1-positive tumors.

The approval was based on a multicenter, single-arm clinical trial that enrolled 50 patients between the ages of 25 and 77, who had metastatic ROS1 rearrangement-positive NSCLC and received 250 mg orally of Xalkori twice a day.

The results were evaluated by an independent radiology review (IRR) and investigators, and the efficacy outcome measures was objective response rate (ORR), according to RECIST v1.0. Duration of response (DoR) was an additional outcome measure.

The tumors were determined to be ROS1 positive by fluorescence in situ hybridization (FISH; 96%) or reverse transcription of polymerase chain reaction (RT-PCR; 4%) clinical trial assays.

The results of the study showed that ORR by IRR was 66% (95% CI: 51%, 79%) and had a median DoR of 18 months. The ORR was reported at 72% (95% CI: 58%, 84%).

Xalkori was first FDA approved in 2011 for treating patients with anaplastic lymphoma kinase (ALK)-positive tumors. The safety results for the current trial were similar to the safety profile of Xalkori, tested in 1,669 patients with ALK-positive metastatic NSCLC.

The most common adverse reactions were nausea, diarrhea, vomiting, constipation, edema, vision disorders, dizziness, elevated transaminases, decreased appetite, fatigue, neuropathy, and upper respiratory infection.

“Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS-1 gene mutation by giving health care practitioners a more personalized way of targeting ROS-1 positive NSCLC.”