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FDA NewsLeukemiaNewsworthy

Besponsa a New Treatment Option for Patients with Relapsed/Refractory B-Cell ALL


December 2017 Vol 3 No 6

On August 17, 2017, the FDA approved the targeted therapy Besponsa (inotuzumab ozogamicin; from Pfizer) for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22.

“For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low. These patients have few treatments available and today’s approval provides a new, targeted treatment option,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

This approval was based on a clinical trial that showed complete response to therapy with Besponsa in more than one-third of patients who received the drug. Serious side effects include liver toxicity, such as veno-occlusive disease or sinusoidal obstruction syndrome, as well as increased risk of death if used after certain stem-cell transplants.

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Last modified: January 2, 2018

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