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Besponsa Approval History

FDA Approved: Yes (First approved August 17, 2017)
Brand name: Besponsa
Generic name: inotuzumab ozogamicin
Dosage form: for Injection
Company: Pfizer Inc.
Treatment for: Acute Lymphoblastic Leukemia

Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Development History and FDA Approval Process for Besponsa

Aug 17, 2017Approval FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
Feb 21, 2017Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration
Jun 12, 2016Pfizer Announces Final Results from Inotuzumab Ozogamicin Pivotal Phase 3 Study in Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia
Oct 19, 2015Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL)
Apr 21, 2015Pfizer Phase 3 Study Of Inotuzumab Ozogamicin Meets Primary Endpoint
May 21, 2013Pfizer Discontinues Phase 3 Study of Inotuzumab Ozogamicin in Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma (NHL) Due to Futility

Further information

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