Breaking News, Trials & Filings

Pfizer Files Crizotinib Applications in U.S., Japan

Pfizer’s NDA for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted Priority Review status by the FDA.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer’s NDA for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted Priority Review status by the FDA. An application has also been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW). “Our ability to file applications for regulatory review in the U.S. and Japan simultaneously only three years after beginning worldwide clinical tr...

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