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news.Pfizer has received the US Food and Drug Adminstration's (FDA) acceptance for filing new drug application (NDA) for Crizotinib as a treatment for the patients who are suffering from ALK-positive advanced non-small cell lung cancer (NSCLC).
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Crizotinib (also known as PF-02341066 or 1066) is an ALK (anaplastic lymphoma kinase) inhibitor of the aminopyridine chemical series.
The FDA has granted priority review status for Pfizer‘s Crizotinib NDA.
Pfizer has also filed NDA for Crizotinib with the Japanese Ministry of Health, Labour and Welfare (MHLW)
Pfizer Oncology Business Unit president and general manager Garry Nicholson said their ability to file applications for regulatory review in the US 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," Nicholson said.