FDA approves Pfizer’s orphan drug for chronic myelogenous leukemia

Hannah Blake

pharmaphorum

Pfizer’s orphan drug, Bosulif, to treat chronic myelogenous leukemia has been approved by the US FDA. Bosulif (bosutinib) is intended for patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to, or who cannot tolerate, other therapies.

“With the approval of tyrosine kinase inhibitors, we are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease. These improvements have been observed in chronic and accelerated phases of CML.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Chronic myelogenous leukemia (CML) is a blood and bone marrow disease that usually affects older adults. It has been estimated that over 5,400 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, called the Philadelphia chromosome.

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Related news:

FDA approves Pfizer’s Bosulif for Ph+ CML (First Word Pharma)

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