Pfizer's Xalkori meets Phase III endpoint

Pfizer Inc. (NYSE:PFE) said Xalkori crizotinib met the primary endpoint of median progression-free survival (PFS) vs. investigator's choice of pemetrexed or docetaxel in the Phase III PROFILE 1007 trial in about 318 patients with previously treated anaplastic lymphoma kinase ( ALK)-positive advanced non-small cell lung cancer (NSCLC). Adverse events observed with Xalkori and chemotherapy were generally consistent with their respective known adverse event profiles. Last year, FDA approved Xalkori to treat locally advanced or metastatic NSCLC in patients whose tumors are ALK-positive, along with its companion ALK FISH test. The drug was approved under the accelerated approval pathway and as part of postmarketing requirements, Pfizer is conducting the Phase III PROFILE 1007 and PROFILE 1014 trials of Xalkori (see BioCentury, Sept. 19, 2011). ...