Posted by Michael Wonder on 14 Nov 2017
Xalkori approved by Health Canada for the treatment of patients with ROS1-positive locally advanced or metastatic non-small-cell lung cancer
14 November 2017 - First Health Canada approved treatment for Canadians with ROS1 non-small-cell lung cancer.
Pfizer Canada announced that Health Canada has expanded the indication of Xalkori (crizotinib) to include its use as a monotherapy in the treatment of patients with ROS1-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). Xalkori was previously approved by Health Canada as a monotherapy for use in patients with anaplastic lymphoma kinase positive locally advanced or metastatic NSCLC.
The Health Canada approval of this expanded indication is based on the final results of Study A8081001, a multicenter, multinational, single-arm Phase 1 study that included 53 patients with ROS1-positive advanced NSCLC treated orally with Xalkori 250 mg twice daily. The primary efficacy outcome measures in this study were objective response rate and duration of response.
