Xalkori(Pfizer)success in Phase III trial in ALK-positive advanced NSCLC

The PROFILE 1007 study met its primary endpoint, demonstrating that Xalkori (crizotinib) from Pfizer significantly improved progression-free survival when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). PROFILE 1007 is the first randomized Phase III study in ALK-positive advanced NSCLC patients. Xalkori received an accelerated approval by the FDA for the treatment of locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test.