The FDA has approved Xalkori (crizotinib; Pfizer) for the treatment of patients with late-stage (locally advanced or metastatic), non-small cell lung cancer (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Xalkori is being approved with a companion diagnostic test (Vysis ALK Break Apart FISH Probe Kit) that will help determine if a patient has the abnormal ALK gene.

Xalkori’s safety and effectiveness were established in two multi-center, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. A sample of a patient’s lung cancer tissue was collected and tested for the ALK gene abnormality prior to study enrollment. The studies were designed to measure objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy. In one study, the objective response rate was 50% with median response duration of 42 weeks. In another, the objective response rate was 61% with median response duration of 48 weeks.

Xalkori is an ALK inhibitor taken as a single-agent treatment, twice daily.

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