FDA Gives Drug for Rare Cancer a Head Start

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Disclaimer: Results are not guaranteed*** and may vary from person to person***.

In more news on the topic, there’s a new drug available for a rare form of cancer — and it’s just received accelerated approval from the U.S. Food and Drug Administration (FDA).

 “Chronic myeloid leukemia,” (also called “chronic granulocytic leukemia”), or CML, is a type of blood cancer  that is seen as usually having a genetic trigger: a specific chromosome. In CML, a person’s bone marrow, which normally manufactures red blood cells, white blood cells, and blood platelets, produces too many white blood cells. These overrun the body and interfere with the production of other types of blood cells.

This slow-progressing cancer is most often found in people who are past their middle years, but children have also been known to develop the disease as well.

Drug giant Bristol-Myers Squibb has created a new medication to treat CML: “Sprycel” (generic name: dasatinib). Sprycel is an innovative drug that could stop bone marrow from going crazy with the white blood cells, allowing normal production of the two types of blood cells and platelets to resume.

There’s already a drug on the market to treat this disease — “Gleevec” (imatinib mesylate) — but most CML patients experience side effects when taking this drug, which are often severe. Therefore an alternative was needed.

Based on four preliminary studies involving CML patients, who were resistant or intolerant to Gleevec and/or other prior treatments, 45% were found to benefit from Sprycel. Essentially, the leukemia cells were totally eliminated or were reduced significantly by at least 65%. As with all drugs, Sprycel did produce side effects, but they were obviously judged as not being severe enough to deny the drug its accelerated approval.

What is “accelerated approval,” you might ask? Well, in special cases (such as with different cancers), the FDA will grant early approval for a promising drug to go to market before it has gone through all the usual clinical trials.

The company producing the drug still has to perform clinical trials, but the drug doesn’t sit in limbo for years while this occurs. This means that new findings down the road might change researchers’ minds about Sprycel, but, for now, it looks like a good option for people with CML.




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