The US Food and Drug Administration (FDA) has approved Pfizer’s Xalkori (crizotinib) capsules for the treatment of patients with locally advanced or metastatic ALK-positive non-small-cell lung cancer.

The approval is based on data from 255 patients with non-small-cell lung cancer across two multi-centre, single-arm studies.

The primary efficacy endpoint in both studies was objective response rate according to response evaluation criteria in solid tumours.

Pfizer is conducting two post-marketing Phase III clinical trials to further evaluate the drug’s clinical benefit.

The first will compare the efficacy and safety of the Pfizer drug with standard-of-care chemotherapy (pemetrexed or docetaxel) in patients with previously treated, advanced, ALK-positive non-small-cell lung cancer.