Pfizer this week announced that it had filed a new drug application with the US Food and Drug Administration for the pharmacogenomically guided non-small cell lung cancer drug crizotinib.
The company is seeking approval for crizotinib in advanced NSCLC patients whose tumors harbor the EML4 and ALK fusion oncogene, and as such a genetic test needs to be marketed with the drug to pick out patients expressing this gene marker.
A FISH test developed by Abbott Molecular is being used to stratify patients in clinical trials for crizotinib. Abbott has previously said that it plans to submit a premarket approval application for commercial companion diagnostic around the same time Pfizer's submits the drug for regulatory approval (PGx Reporter 01/19/2011).
An Abbott spokesperson told PGx Reporter this week that the company "is expected to announce the completion of its FDA submission shortly."
In December 2010, the FDA granted Pfizer's crizotinib NDA Fast Track status, a designation that speeds the review of drugs for serious or life-threatening diseases and for an unmet medical need. With Fast Track status, Pfizer began a rolling submission process with the FDA.
Now with the NDA submitted, the FDA has granted Priority Review status to the complete submission, which shortens the review time from 10 months, under the Fast Track process, to six months. According to Pfizer, the regulatory filings come three years after beginning worldwide clinical trials for crizotinib.
Crizotinib also has orphan drug designation, since the drug is indicated for such a limited population. Pfizer estimates that between three percent and five percent of NSCLC tumors are ALK-positive.
While Pfizer is submitting its application with the FDA in the US, the company has also submitted a regulatory filing with the Japanese Ministry of Health, Labor, and Welfare for crizotinib as a treatment for patients with ALK-positive advanced NSCLC. "These filings represent the first simultaneous filings in Japan and the US for a non-Japanese-based pharmaceutical company," Pfizer said in a statement.
The Abbott spokesperson could not discuss specific markets outside the US where it expects to file for regulatory approval of the companion test, but said the company "has submitted or is in the process of submitting for regulatory approval in other key global markets."
In Japan, Pfizer commenced crizotinib clinical trials in March 2010, and Japanese health regulators granted the drug orphan drug status in January 2011. The presence of the ALK fusion gene in lung tumors was first reported by researchers from Jichi Medical University, University of Tokyo, Japanese Foundation for Cancer Research, and the Japan Science and Technology Agency in 2007. Studies suggest that crizotinib's inhibitory activity against ALK cuts off cell signaling pathways that tumor cells depend on for growth and survival.