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New "Orphan" Drug for Melanoma

By December 15, 2008

Last week, the US Food and Drug Administration granted the experimental agent tesetaxel "orphan drug" status for treatment of patients with advanced melanoma.

Tesetaxel is a new member of the taxane group of drugs, which attack cancer cells by interfering with their microtubules (cellular structures that help move chromosomes during cell division). It is novel in that it is taken in convenient pill form and may have fewer side effects than other taxanes such as paclitaxel and docetaxel. It is currently being studied in a phase II clinical trial.

The "orphan" drug program was started by the FDA in the 1980s to encourage development of experimental agents that treat diseases that affect fewer than 200,000 people. It gives pharmaceutical companies tax breaks and other incentives to induce them to undertake the development and manufacturing of such drugs, which otherwise might not be profitable because of the small potential market.

Other recently designated orphan drugs for melanoma include melphalan (by direct infusion into the liver), ALS-357, thymalfasin, ADH-1, triphendiol, VEGFb, elesclomol, and others. If you have been diagnosed with advanced (stage III or IV) melanoma, be sure to ask your physician if you are eligible for the clinical trials investigating these promising drugs.

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