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 In Industry News

The US Food and Drug Administration has approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (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,’ commented Richard Pazdur, MD, Director of the FDA’s Oncology Centre of Excellence and Acting Director of the Office of

Haematology and Oncology Products in the FDA’s Centre 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 the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in America will be diagnosed with ALL this year and approximately 1,440 will die from the disease.

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.

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