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Besponsa FDA Approval History

Last updated by Judith Stewart, BPharm on March 11, 2024.

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 indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.

Development timeline for Besponsa

DateArticle
Mar  6, 2024Approval FDA Approves Besponsa (inotuzumab ozogamicin) for Pediatric Patients with Acute Lymphoblastic Leukemia
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

See also

Besponsa (inotuzumab ozogamicin) Consumer information

Further information

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