The Food and Drug Administration today approved the drug vismodegib to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug, marketed under the brand name Erivedge by Genentech in South San Francisco, is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation. The drug can also be used with patients whose cancer has spread to other parts of the body.
Basal cell carcinoma (BCC) is a type of non-melanoma skin cancer, and is the most common form of cancer in the United States. According to the American Cancer Society, eight in 10 of all skin cancers are basal cell carcinomas. Basal cell carcinoma tends to be slow growing, where the cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation. Left untreated, however, basal cell cancer can grow into nearby areas and invade the bone or other tissues beneath the skin.
Erivedge is a pill 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. Erivedge is the first FDA-approved medicine for people with advanced forms of BCC.
Approval of Erivedge by FDA was based on results from a phase II clinical trial that enrolled 104 patients with advanced BCC, including patients with the locally advanced and metastatic varieties of the condition. The study showed Erivedge shrank lesions in 43 percent (27 of 63 cases) of patients with locally advanced BCC and 30 percent of patients (10 of 33 cases) with metastatic BCC. The median duration of response was 7.6 months.
FDA’s approval of Erivedge requires a boxed warning alerting patients and health care professionals of potential risks of death or severe birth effects to a fetus. Because of this danger, FDA is requiring that pregnancy status be verified prior to the start of Erivedge treatment, with male and female patients cautioned about these risks and the need for birth control.
Erivedge was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment. Roche has also submitted a marketing authorization application (MAA) for Erivedge in the European Union. The company is carrying out a phase 2 safety study in the EU and other countries that is enrolling patients with advanced BCC.
* * *