BioCentury
ARTICLE | Top Story

FDA grants full approval to Pfizer's Xalkori

November 22, 2013 1:24 AM UTC

FDA granted full approval to Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) to treat metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. In 2011, the agency granted Xalkori accelerated approval to treat locally advanced or metastatic ALK-positive NSCLC, along with its companion ALK FISH test, based on objective response rate (ORR) data from two single-arm open-label trials (see BioCentury, Sept. 19, 2011).

Xalkori's full approval was based on data from the Phase III PROFILE 1007 trial, which Pfizer conducted as part of its postmarketing requirements for the accelerated approval. Last year, the pharma reported that Xalkori met the primary endpoint of median progression-free survival (PFS) vs. investigator's choice of pemetrexed or docetaxel in the trial (7.7 vs. 3 months, p<0.0001) (see BioCentury Extra, June 19, 2012). ...