The FDA has granted regular approval for Xalkori (crizotinib; Pfizer) capsules for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.  

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The FDA approval is based on the demonstration of higher progression-free survival (PFS) and overall response rate (ORR) for Xalkori-treated patients vs. chemotherapy in patients with ALK-positive NSCLC with disease progression after platinum-based double chemotherapy.

The randomized, open-label, active-controlled, multinational trial (n=347) randomized patients with ALK-positive, metastatic NSCLC to receive either Xalkori 250mg twice daily (n=173) or chemotherapy (n=174). Patients in the chemotherapy arm received pemetrexed or docetaxel if they had received pemetrexed before.

Results showed a significantly prolonged progression-free survival for the Xalkori-arm vs. the chemotherapy arm (HR=0.49, 95% CI: 0.37, 0.64; P<0.0001). Median PFS was 7.7 months and 3.0 months for the Xalkori and chemotherapy arms, respectively.

The ORR was also significantly higher for the Xalkori arm (65% vs. 20%) with median response durations of 7.4 and 5.6 months in the Xalkori and chemotherapy arms, respectively. In addition, no difference in overall survival was noted between the two arms (HR=1.02, 95% CI: 0.68, 1.54).

Xalkori was granted accelerated approval in August 2011 based on ORR data of 50% and 61% in two single-arm, open-label trials.

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