Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In 2015, the FDA granted Breakthrough Therapy and Priority Review designations for this indication. XALKORI also is indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
The approval is based on a multicenter, single-arm Phase 1 study (Study 1001) that included 50 patients with ROS1-positive metastatic NSCLC treated with 250 mg of XALKORI orally twice daily. The efficacy outcome measures in this study were objective response rate and duration of response.1
The results of this study showed that XALKORI exhibited marked anti-tumor activity in patients with ROS1-positive metastatic NSCLC, with an objective response rate of 66 percent (95% CI: 51%, 79%) by an independent radiology review. There was one complete response and 32 partial responses. The median duration of response was 18.3 months (95% CI: 12.7 months, not reached). Additionally, the safety profile of XALKORI in ROS1-positive metastatic NSCLC was generally consistent with that observed in patients with ALK-positive metastatic NSCLC.
Additionally, the European Medicines Agency (EMA) is reviewing an application to extend the marketing authorization of XALKORI to include the treatment of adult patients with ROS1-positive advanced NSCLC. In Europe, XALKORI is indicated for the first-line treatment of adults with ALK-positive advanced NSCLC and for the treatment of adults with previously treated ALK-positive advanced NSCLC.
