Skin Cancer Drug Approved for Speedy Review

Posted on Feb 05, 2012

A new drug has just been placed on the fast-track review process by the FDA for treating the most common form of skin cancer.

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Basal cell carcinoma is produced by prolonged sun or any other ultraviolet exposure. It gestates in the outer layer of skin and slowly grows from there, usually without pain.

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The drug, known as Erivedge, treats locally advanced basal cell carcinoma in adult patients who are unsuitable for surgery or radiation. It is administered as a once-a-day pill and acts to block the Hedgehog pathway, a directional route for signaling proteins, which transport messages for the development of certain organs. The Hedgehog pathway sometimes malfunctions and enables basal cell carcinoma. This kind of cancer-battling treatment, which targets molecular pathways, is becoming more common as a technique that is more effective, with potentially fewer side effects.

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This drug was given to 96 patients with basal cell carcinoma. 30% of patients with advanced metastatic cancer achieved a partial tumor shrinkage. 43% with locally advanced cancer achieved a complete or partial shrinkage.

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The FDA has given early approval to Erivedge under guidelines that favor drugs that represent major or novel advances in treatment.

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Erivedge's potential side effects are extensive, but less than those of other skin cancer treatments: "hair and weight loss, muscle spasms, fatigue, nausea, diarrhea, decreased appetite, distorted sense of taste, vomiting, constipation, and loss of taste in the tongue." Pregnant women should also consult their doctors because of potential mortality or birth defect risks in newborns.

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Gerry practices law exclusively in the State of New York. Within New York he practices primarily in the following counties: New York, Brooklyn, Queens, Bronx, Staten Island, Nassau and Suffolk. Technically, Brooklyn is known as "Kings County," and Manhattan and New York City are known as "New York County." Staten Island is known as "Richmond County." These counties make up the New York metropolitan area.

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