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  • FDA Approves New Skin Cancer Drug Erivedge

    erivedge_packaging

    For the first time, the most common type of skin cancer, basal cell carcinoma (BCC), has a miracle drug to treat it. This pill is called Erivedge. The Food and Drug Administration (FDA) approved the drug on January 30th of this year. Genentech, a division of Swiss drug company Roche and creator of Erivedge (vismodegib), says that the new drug will be available in one or two weeks from now. Adult BCC patients who are not candidates for surgery and whose cancer has metastasized to other parts of the body can take Erivedge once a day and find themselves cured. The FDA announced that it would decide whether or not to approve Erivedge by March 8th of this year, and it approved the drug early.

    The FDA hurried its drug assessment since it is the first drug available to treat BCC. It took the FDA only six months to evaluate Erivedge before approving it.

    Women who are pregnant should not take Erivedge. Women must use highly efficient birth control while taking Erivedge as well as six months after their last dose of Erivedge. Men taking Erivedge must always use a condom with spermicide so as not to impregnate their partners, even if they have had a vasectomy. Men should continue using efficient protection for two months after their last dose of Erivedge. The drug has been linked to severe birth defects and fetal death.

    Side effects of Erivedge include fatigue, joint pain, weight loss, hair loss, muscle spasms, diarrhea, changes or loss in sense of taste, constipation, vomiting and decreased appetite. This drug has not been tested in children with basal cell carcinoma. Patients cannot donate blood or blood products while taking Erivedge and for seven months after their last dose. Since June 2011, Erivedge has been in testing for treatment of small-cell lung cancer, advanced stomach cancer, chondrosarcoma, metastatic colorectal cancer and medulloblastoma.

    About 2.8 million Americans are stricken with basal cell carcinoma each year. Although BCC is usually not fatal, once the cancer metastasizes to other pats of the body it becomes fatal. Erivedge is a Hedhehog pathway inhibitor and is intended for patients with advanced cases of BCC. Candidates for Erivedge include those whose BCC recurred following surgical removal of the metastatic tumor and for those patients who are not candidates for surgery or radiation.

    While an embryo is developing, the Hedgehog signaling pathway directs cells by telling them where they should grow into different body parts. The Hedgehog signaling pathway ensures that embryos properly mature and develop. When the pathway does not function accordingly, basal cell carcinoma can result.

    Erivedge works as a cyclopamine-competitive antagonist of the smoothened receptor (SMO) on the Hedgehog signaling pathway. By hindering SMO, the transcription factors GLI1 and GLI2 are forced to remain inactive. The transcription factors’ inactivity prevents the expression of tumor genes within the Hedgehog pathway. The Hedgehog pathway is involved in over 90% of BCC tumors.