EC approves Xalkori for NSCLC

The European Commission conditionally approved an MAA from Pfizer Inc. (NYSE:PFE) for Xalkori crizotinib to treat previously treated, advanced non-small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase ( ALK)-positive. As part of the approval, Pfizer is required to submit data to EMA from the recently completed Phase III PROFILE 1007 trial. Pfizer said the EC may convert the conditional approval to full approval after reviewing the data. In June, Pfizer reported data from PROFILE 1007 showing that Xalkori met the primary endpoint of median progression-free survival (PFS) vs. investigator's choice of pemetrexed or docetaxel. ...