FDA approves Pfizer’s leukemia drug Besponsa

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug from Pfizer, Besponsa (inotuzumab ozogamicin). The drug is indicated to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, or ALL.

"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," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "These patients have few treatments available and today's approval provides a new, targeted treatment option."

B-cell precursor ALL is a rapidly progressing type of cancer in which a patient’s bone marrow makes too many of an immature type of white blood cell. The National Cancer Institute estimates that roughly 5,970 people will be diagnosed with it this year, and that 1,440 will die from the illness.

“Besponsa will help address a significant need for new treatment options in B-cell acute lymphoblastic leukemia, and may help more patients reach stem cell transplant, which provides the best chance for long term remission,” Pfizer Oncology global president Liz Barrett said. “We’re proud to build on our continued commitment to patients with hematologic malignancies, and will continue our work to find new treatments in acute lymphoblastic leukemia and other blood cancers.”