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FDA Okays Sprycel for CML Resistant or Intolerant to Gleevec

FDA Okays Sprycel for CML Resistant or Intolerant to Gleevec

ROCKVILLE, Md., June 29 — The FDA today granted accelerated approval to Sprycel (dasatinib) for adults with chronic myeloid leukemia who are intolerant to Gleevec (imatinib) or become resistant to it.

The FDA also gave standard approved to the agent for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy.

Sprycel will be available nationwide within days, according to Bristol-Myers Squibb, the drug maker.

Known mechanisms of resistance to Gleevec, which was approved in 2001, include mutations in the protein sequence of the BCR-ABL tyrosine kinase, multidrug resistance gene overexpression, and the activation of alternate signaling pathways involving the SRC family kinases.

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