European Commission approves Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).- Pfizer

Pfizer Inc. announced that the European Commission has approved Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). In the European Union , Xalkori is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In March of this year, Xalkori was approved by the United States FDA for patients with metastatic NSCLC whose tumors are ROS1-positive. With this approval, Xalkori becomes the only biomarker-driven therapy approved for patients with either ALK positive or ROS1-positive advanced NSCLC in the EU and U.S.

The European Commission�s approval of Xalkori in patients with ROS1-positive advanced NSCLC follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine�s Agency, and is supported by compelling results from a multicenter, single-arm Phase 1 study (Study 1001) that included patients with ROS1-positive advanced NSCLC treated with 250 mg of Xalkori orally twice daily. The efficacy outcome measure in this study was objective response rate (ORR) by RECIST. Secondary endpoints included time to tumor response (TTR), duration of response (DOR) and progression-free survival (PFS). Tumors were tested for ROS1 rearrangements by laboratory-developed break-apart fluorescence in situ hybridization (FISH) (96%) or real-time polymerase chain reaction (RT-PCR) (4%) assay. The results of this study showed that Xalkori exhibited marked anti-tumor activity in patients with ROS1-positive advanced NSCLC and met its primary endpoint of ORR. Additionally, the safety profile of Xalkori in ROS1-positive advanced NSCLC was generally consistent with that observed in patients with ALK-positive advanced NSCLC.