Confident Pfizer Incorporated announced today that it will submit its new drug crizotinib for approval both to the FDA and the Japanese Ministry of Health, Labor and Welfare (MHLW) after receiving “fast track” status by the FDA in 2010. Crizotinib is the first of its kind of medication intended to treat cellular lung cancer (NSCLC).
Garry Nicholson, president and general manager, Pfizer Oncology Business Unit comments:
“Our ability to file applications for regulatory review in the U.S. and Japan simultaneously only three years after beginning worldwide clinical trials in patients with ALK-positive lung cancer is a testament to the hard work of the crizotinib team and the productive discussions that we have had with the respective regulatory agencies. Given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced NSCLC.”
Crizotinib received orphan drug designation from the FDA in September 2010 and was granted Fast Track status in December 2010. As a result of the Fast Track designation, Pfizer initiated a rolling submission of crizotinib in January 2011. The FDA’s Fast Track process is designed to facilitate development and expedite review of drugs that treat serious or life-threatening diseases and demonstrate the potential to address unmet medical need.
In Japan, Pfizer commenced crizotinib clinical trials for patients with ALK-positive advanced NSCLC in March 2010, and crizotinib was granted orphan drug status in January 2011. These filings represent the first simultaneous filings in Japan and the U.S. for a non-Japanese-based pharmaceutical company.
Worldwide, lung cancer is the leading cause of cancer death in men and the second leading cause of cancer death in women. NSCLC accounts for about 85% of lung cancer cases and remains difficult to treat, particularly in the metastatic setting. Approximately 75% of NSCLC patients are diagnosed late with metastatic, or advanced, disease, where the five-year survival rate is only 6 percent. In addition, the current standard of care for advanced NSCLC demonstrates a response rate of about 15-35%.
The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.
The FDA Fast Track and Priority Review processes are explained on the Admistration’s website as the following:
“Fast Track addresses a broad range of serious diseases. Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one…A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.”
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Written by Sy Kraft