The therapy, Besponsa, treats a rapidly progressing version of the disease.
The treatment, Besponsa (or inotuzumab ozogamicin) is approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Nearly 6,000 Americans are diagnosed with the condition annually and more than 1,400 die from it every year.
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What makes this form of ALL so deadly is that it progresses rapidly because too many immature white blood cells are produced in the bone marrow, the FDA explains. “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 the FDA’s Dr. Richard Pazdur in a statement. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”
Other companies have also been working on new therapies for various types of ALL—including on a groundbreaking new type of treatment called chimeric antigen receptor T-cell (CAR-T) technology, which involves turning a patient’s own cells into targeted cancer killers. Pharma giant Novartis recently received the unanimous recommendation of an expert panel that advises the FDA for approval of its CAR-T therapy CTL019.