FDA approves Erivedge for most common type of skin cancer
(CBS/AP) The FDA has approved a new drug called Erivedge to treat basal cell carcinoma, the most common form of skin cancer.
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Federal regulators announced Monday the approval of the Erivedge pill, the first drug ever approved for treating basal cell carcinoma. Typical BCC treatments include outpatient procedures such as freezing or surgically removing the cancerous area.
The pill is made by Genentech, a unit of Swiss drugmaker Roche. Erivedge is a once-per-day capsule that's intended to treat locally advanced cancer for patients who are not candidates for surgery or radiation, and for patients whose cancer has spread to other parts of the body.
Genentech said the drug will be available within one to two weeks.
The drug's label will warn that it is linked to fetal death and severe birth defects when it is used by pregnant women. The most common side effects of Erivedge include muscle spasms, hair loss, weight loss, diarrhea, fatigue, changes or loss in sense of taste, decreased appetite, constipation, and vomiting.
Curis Inc. of Lexington, Mass., which collaborated with Genentech on the drug, is getting a $10 million payment from Genentech now that the drug has been approved.
The approval comes ahead of schedule, as the FDA previously said it would make a decision on Erivedge by March 8. The drug was given a fast six-month review because there are no approved treatments for basal cell carcinoma.
Basal cell carcinomas strike an estimated 2.8 million Americans each year. BCCs are not usually fatal, but can be very disfiguring if they continue to grow, according to the Skin Cancer Foundation. In rare cases, a BCC can spread to other parts of the body, becoming deadly.
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This article would be fairly complete, and certainly a service to readers, if only it provided them with a more accurate idea of the effectiveness of Erivedge.
The new drug is presented as an alternative to surgery, and common contraindications are listed, but efficacy is simply not discussed.
We can only presume the FDA did not release that information. Unfortunately, with FDA press releases, the FDA indicates only what it wants the public to know.
But the efficacy measure is particularly important, because the FDA has made some very questionable calls on drug approvals in the past when natural alternatives were equally (if not more) effective-- without possible drug complications.
Based on the fact efficacy is almost the first question in the minds of most patients, it is all the more notable the FDA omitted information on Erivedge efficacy.
In fact, this FDA "fast track" for release of drugs to the American market is notorious for rapid approval of expensive but still questionable drugs by the pharmaceutical majors. And notorious for denial of approval to still other, more promising drugs, without a plausible, research basis.
Clearly enough, the object of the pharmaceuticals is to turn on the money spigot as quickly as possible. As Dr. David Graham learned in a confrontation with his FDA management, the mission of the FDA is to make the market safe for the drug manufacturer-- not the patient.
See-- http://www.cbsnews.com/stories/2005/02/15/60II/main674293.shtml