The drug’s generic name is vismodegib and was developed by the US part of Roche Holding AG. It will be sold in the US by Roche’s South San Francisco-based Genentech under the brand name Erivedge.
Basal cell carcinoma is a slow growing, painless cancer that starts in the epidermis, the top layer of skin. It usually starts in places that are regularly exposed to the sun or UV light.
The once-a-day capsule drug works by inhibiting the Hedgehog pathway, which is active in most basal cell cancers and only a few normal tissues, such as hair follicles.
Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research at the FDA, said as we get to know more about the Hedgehog pathway and others important to cancer, we can develop more drugs that target specific diseases:
“This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects,” he explained.
Erivedge is designed for patients with locally advanced basal cell carcinoma, who are not having surgery or radiation therapy, and also for patients whose cancer has spread to other parts of the body (has become metastatic). It is the first FDA-approved drug for metastatic basal cell carcinoma.
The FDA reviewed Erivedge through its priority fast-track program, where it only takes six months to review drugs that show promise of major advances in treatment.
The review took into account a study that tested the safety and effectiveness of Erivedge. The study was a single, multi-center clinical trial in 96 patients whose basal cell carcinoma was either locally advanced or metastatic.
After taking Erivedge, 43% of patients with locally advanced disease showed a partial response or complete shrinkage or disappearance of the cancerous lesions, and 30% of the patients with the metastatic form of the disease showed a partial response.
The most common side effects were hair loss, muscle spasms, weight loss, fatigue, reduced appetite, distorted sense of taste, loss of taste function in the tongue, nausea, constipation, vomiting, and diarrhea.
The drug must carry a Boxed Warning telling patients and doctors about the potential risk of death or severe birth defects to an unborn child.
Women must check they are not pregnant before starting on Erivedge, and patients should be warned of these risks and the need for birth control before starting on the drug, said the FDA in a statement.
For more FDA information on Erivedge go to Drugs@FDA and enter “Erivedge” in the search box.
Written by Catharine Paddock PhD