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FDA Approves New Treatment for Acute Lymphoblastic Leukemia

THURSDAY, Aug. 17, 2017 -- The U.S. Food and Drug Administration on Thursday approved Besponsa (inotuzumab ozogamicin) to treat B-cell acute lymphoblastic leukemia (ALL).

Besponsa was evaluated in clinical studies involving 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments with other medication. After taking Besponsa, 35.8 percent of patients evaluated achieved complete remission for about eight months, compared with 17.4 percent of those who took a different chemotherapy drug.

Common side effects of Besponsa included thrombocytopenia, neutropenia, leukopenia, infection, anemia, fatigue, and severe bleeding. The drug's label includes a boxed warning of possible severe liver damage. Pregnant or breastfeeding women shouldn't take Besponsa, the FDA said.

"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," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement. "These patients have few treatments available and today's approval provides a new, targeted treatment option."

Approval was granted to Pfizer, based in New York City.

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Posted: August 2017

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