17 August 2017 - The U.S. FDA today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.

“For adult patients with B-cell acute lymphocytic leukaemia whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., 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.”

The FDA granted this application priority review and breakthrough therapy designations. Besponsa also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Read FDA press release