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FDA Grants Priority Review to Pfizer's Crizotinib

John Eichorn
Published: Thursday, May 19, 2011

Mace L. Rothenberg, MD

Mace L. Rothenberg, MD

Crizotinib, an oral anaplastic lymphoma kinase (ALK) inhibitor from Pfizer targeted to ALK-positive non–small cell lung cancer (NSCLC), was accepted for filing by the FDA and granted Priority Review status. Pfizer has also filed for approval in Japan with the Japanese Ministry of Health, Labour, and Welfare.

It was just 4 years ago, in 2007, that a link between the ALK fusion gene and lung cancer was discovered. Preliminary testing has indicated that about 3% to 5% of patients with  are ALK-positive, and about 40,000 new patients are diagnosed each year. Crizotinib works to inhibit ALK and therefore impedes the growth of tumor cells. Pfizer said it hopes to have FDA approval of crizotinib by the end of this year.

In an early-stage clinical trial, researchers noted that 64% of patients taking crizotinib for NSCLC were alive after 2 years; 77% of patients were alive after 1 year. The study involved 82 patients with NSCLC who were previously treated for the disease. The researchers noted that median overall survival is not yet available because more than half the patients are still alive. This study will be presented at the annual meeting of the American Society of Clinical Oncology next month in Chicago, Illinois.

Considering that the typical drug-approval time frame is 8 to 10 years, crizotinib’s relatively speedy FDA submission is impressive. Mace Rothenberg, MD, the senior vice president of clinical development and medical affairs in Pfizer’s oncology unit, said it is “remarkable” that crizotinib may be introduced to the market 4 to 5 years after the disease target was discovered. “The risk/benefit ratio in this area of unmet medical need was viewed as compelling by all who saw it,” Rothenberg told OncLive.

In March 2010, Pfizer started clinical trials in Japan in patients with ALK-positive advanced NSCLC. Crizotinib was granted orphan drug status in September 2010 and was subsequently given Fast Track status in December 2010.

Abbott Laboratories, which has developed a screening test to detect the ALK mutation, will partner with Pfizer to identify these patients with ALK-positive NSCLC. An Abbott spokeswoman said that the company plans to file for FDA approval shortly and it is hoped that both Abbott’s screening test and Pfizer’s crizotinib will be approved at the same time.


Shaw AT, Yeap BY, Solomon BJ, et al. Impact of crizotinib on survival in patients with advanced, ALK-positive NSCLC compared with historical controls. J Clin Oncol. 2011. (suppl; abstract 7507).



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