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Published On: Sun, Sep 9th, 2012

FDA approves Bosulif to treat CML

The U.S. Food and Drug Administration (FDA) announced last week the approval of Pfizer’s Bosulif, a drug to treat the blood and bone marrow disease, chronic myelogenous leukemia (CML).

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, including imatinib. Bosulif works by blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes.

Other drugs recently approved by FDA to treat various forms of CML include imatinib (2001), dasatinib (2006) and nilotinib (2007) are other drugs that also inhibit tyrosine, but in different ways.

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

An estimated 5,430 men and women will be diagnosed with CML in 2012.

The FDA approved Bosulif based on a Pfizer study showing 34 percent of patients treated with the drug responded within the first six months of treatment. In patients previously treated with Gleevec, 33 percent had blood counts that returned to a normal range within 48 weeks. Fifty five percent of patients achieved normal blood counts with no evidence of leukemia within that same timeframe.

The most common side effects seen in patients included diarrhea, nausea, abdominal pain, rash and fever.

Chronic myelogenous leukemia (also called CML or chronic granulocytic leukemia) is a slowly progressing blood and bone marrow disease that usually occurs during or after middle age, and rarely occurs in children.

Normally, the bone marrow makes blood stem cells (immature cells) that become mature blood cells over time.

In CML, too many blood stem cells become a type of white blood cell called granulocytes. These granulocytes are abnormal and do not become healthy white blood cells. They are also called leukemia cells. The leukemia cells can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or easy bleeding may occur.

 

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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