News Article: Sprycel Approved as Frontline CML Treatment

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Sprycel Approval Expanded to Include Rare Leukemia

Drug believed to hinder proteins that encourage cancer growth

THURSDAY, Oct. 28 (HealthDay News) -- Sprycel (dasatinib) has received an

additional approval from the U.S. Food and Drug Administration to treat a rare

form of blood cancer called Philadelphia chromosome positive chronic phase

chronic myeloid leukemia (Ph+ CP -CML), the agency said Thursday in a news

release.

CML is a slowly progressive disease of the blood and bone marrow that's believed

related to a genetic abnormality, the FDA said.

Sprycel is among a class of drugs called oral kinase inhibitors, which are

thought to inhibit certain proteins that foster growth of cancer cells. The drug

was first approved in 2006 to treat other forms of CML that are resistant to

standard therapies, including the Novartis anti-cancer drug Gleevec.

Sprycel's side effects could include decreased bone marrow activity, fluid

retention, diarrhea, headache, muscle and bone pain, and rash.

Sprycel's maker, New York City-based Bristol-Myers Squibb, is required as a

condition of approval to conduct ongoing clinical studies of the drug's

long-term effectiveness for this condition, the FDA said.

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