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New FDA Approval for Pfizer's BESPONSA®

On Thursday, August 17, 2017 Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.

BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The full Prescribing Information, including BOXED WARNING, for BESPONSA can be found at http://labeling.pfizer.com/ShowLabeling.aspx?id=9503