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.