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Pfizer’s XALKORI® (crizotinib) Approved by FDA

On August 26, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive. The effectiveness of XALKORI is based on objective response rates (ORR) and, as XALKORI received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.

Not only is this the first and only therapy specifically for patients with locally advanced or metastatic ALK-positive NSCLC, it is also the first new drug approved for lung cancer in the U.S. in more than six years.

Lead inventor of drug compound is a Chinese American scientist Dr. Jingrong Jean Cui at Pfizer. She is the first author of the patent for Crizotinib as well as the lead author of a recently published paper on Journal of Medicinal Chemistry describing the design of this specific drug molecule. Dr Cui graduated from the University of Science and Technology of China (B.S.,1985, M.S. 1988). She received her Ph.D. from Ohio State University and conducted postdoctoral research at Lawrence Berkeley National Laboratory. Dr. Cui had since worked in several biopharma companies including Glycomed, Ligand, Corvas, SUGEN/Pharmacia. She is currently an Associate Research Fellow at Pfizer La Jolla R&D Center.

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