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Xalkori Approval History

  • FDA approved: Yes (First approved August 26th, 2011)
  • Brand name: Xalkori
  • Generic name: crizotinib
  • Company: Pfizer Inc.
  • Treatment for: Non-Small Cell Lung Cancer

Xalkori (crizotinib) is an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive.

Development History and FDA Approval Process for Xalkori

Aug 26, 2011Approval FDA Approves Xalkori with Companion Diagnostic for a Type of Late-Stage Lung Cancer
May 17, 2011Pfizer Announces Simultaneous Filing Of New Drug Applications For Crizotinib With U.S. Food And Drug Administration And Japanese Ministry Of Health, Labour And Welfare
Jan 12, 2011Pfizer Initiates Rolling Submission For A New Drug Application In The U.S. For Its Fast-Tracked Investigational Compound Crizotinib (PF-02341066) For Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer

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