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FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.
On August 17, 2017, Pfizer announced that FDA approved Besponsa (inotuzumab ozogamicin), a new molecular entity for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The drug was reviewed and approved under FDA’s breakthrough therapy designation and priority review programs.
Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells, according to FDA.
“The approval of Besponsa is an important step forward for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, a rare disease that can be fatal within a matter of months if left untreated,” said Liz Barrett, global president, Pfizer Oncology, in a company press release. “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. 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.”
“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 Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, in an agency press release. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”
The prescribing information for Besponsa includes a boxed warning that severe liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease [VOD] or sinusoidal obstruction syndrome), occurred in some patients who took Besponsa. The boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.