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Xalkori Approval History

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

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive.

Development History and FDA Approval Process for Xalkori

Mar 11, 2016Approval FDA Expands Use of Xalkori (crizotinib) to Treat ROS-1 Positive Non-Small Cell Lung Cancer
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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