Roche Advanced Skin Cancer Drug Approved in Europe

(NOAA)

The global pharmaceutical company Roche says its drug vismodegib, marketed under the name Erivedge, received conditional approval in Europe as a treatment for adults with advanced cases of basal cell carcinoma, a form of skin cancer. Approval for the the drug, taken once a day in capsule form, is limited to cases of basal cell carcinoma that metastasize,  are left untreated, or recur, and cannot be treated with surgery or radiation. The approval is also conditioned on Roche providing  data from a continuing safety study of the drug.

Basal cell carcinoma results in abnormal uncontrolled growths or lesions on the skin, usually arising from long-term or excessive exposure to the sun. Most cases are simple and can be controlled, but advanced cases can become disfiguring or spread to nearby tissue and other parts of the body. Roche’s Genentech subsidiary that developed Erivedge says some 2.8 million cases of basal cell carcinoma are diagnosed each year in the U.S., making it the most frequently occurring form of cancer.

Erivedge targets  and blocks abnormal activity in the hedgehog signaling pathway, a cellular growth mechanism active in embryonic development, but normally inactive in adult tissues. Genetic mutations can revive the pathway, causing the abnormal activity associated with basal cell carcinoma.

An intermediate stage clinical trial tested Erivedge with 104 patients in the U.S., Europe, and Australia having either locally advanced or metastatic basal cell carcinoma. The results show the drug shrank lesions in 43 percent of the patients with locally advanced basal cell carcinoma and 30 percent of those with the metastatic form. About a quarter (26 of 104) of the patients experienced serious adverse effects during the trial –muscle spasms, hair loss, altered taste sensation, fatigue, and weight loss — but only four of those cases, says the company, were related to the treatments.

The European Commission’s conditional marketing authorization is granted to therapies considered having more benefits than risks, that satisfy an unmet medical need, and would result in a significant benefit to public health. In January 2012, the U.S. Food and Drug Administration approved Erivedge following the agency’s accelerated review. The company says Erivedge is the first drug approved in the U.S. and Europe to treat advanced basal cell carcinoma.

Erivedge was first developed and validated by Roche’s Genentech subsidiary and Curis Inc., a cancer drug development company in Lexington, Massachusetts. Under its licensing agreement, Curis earns a milestone payment of $6 million from Genentech, and will be eligible for royalties on future sales of the drug.

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Hat tip: FirstWord Pharma

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