FDA Approves Roche/Genentech Drug Erivedge to Treat Advanced Skin Cancer Not Treatable with Surgery

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Basal cell carcinoma is rarely fatal and in many cases surgery is the cure but in some patients is can spread beyond the skin area in to other areas of the body and this is where the new oral drug comes in to help fight and shrink tumors.  image

When the cancer has metastasized, this is about the only option available.  There are a few side effects like loss of hair and food tasting different but the benefits seem to certainly outweigh. The pill is taken once a day and the cost will be around $7k a month.  I do hope insurers start to cover this as it has been an issue in California with covering oral cancer medications.  BD

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The Food and Drug Administration has for the first time approved a drug to treat advanced cases of the most common skin cancer, basal cell carcinoma, the agency announced Monday.

The drug, a capsule called Erivedge (generically known as vismodegib), treats basal cell carcinoma that has metastasized (spread through the body), or that cannot be treated with surgery.

In a clinical study in 96 people, 30 percent of those with locally advanced basal cell carcinoma (which had spread to surrounding tissue), and 43 percent of those with metastatic cancer (which had spread to distant sites in the body) saw their tumors shrink or heal while taking the drug, according to a statement from the FDA. Patients took one pill by mouth each day. 

Doctors treat non-metastatic cases with surgery, radiation or topical treatments, and have an extremely high success rate. But no other treatments exist for inoperable cases, such as people with tumors that have extended into the brain, or people who would become disfigured from surgery

Basal cell carcinoma is linked to mutations in genes that are part of a signaling pathway called the hedgehog pathway. Erivedge works by inhibiting the hedgehog pathway.


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