Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Xalkori is 2,054 days for extending a patent which claims the human drug product. Xalkori (crizotinib) is a kinase inhibitor indicated for treating patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase-positive as detected by an FDA-approved test. To view this notice, click here.
