FDA Approves Vismodegib for Basal Cell Carcinoma

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FDAlogoThe FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic disease.

Vismodegib is the first FDA-approved drug for metastatic basal cell carcinoma. The drug was reviewed under the FDA’s priority review program, which provides for an expedited 6-month review of drugs that may offer major advances in treatment.

An oral agent, vismodegib is taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

The safety and effectiveness of vismodegib was evaluated in a single, multicenter clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma. The clinical study’s primary endpoint was objective response rate (ie, complete plus partial response). Of the patients with metastatic disease receiving vismodegib, 30% experienced a partial response and 43% of patients with locally advanced disease experienced a complete or partial response.

The most common side effects observed in patients treated with vismodegib were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.

Vismodegib is being approved with a Boxed Warning alerting patients and health-care professionals of the potential risk of death or severe birth effects to a fetus. Pregnancy status must be verified prior to the start of treatment. Male and female patients should be warned about these risks and the need for birth control. ■




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