Genentech’s Erivedge (vismodegib) has been approved by the FDA 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 whose cancer has spread to other parts of the body (metastatic).
Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma and was reviewed under the FDA’s priority review program, which expedites the review process for drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012 prescription user fee goal date.
Erivedge is a pill taken daily 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.
“Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” said Richard Pazdur, M.D., director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research. “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.”
The safety and effectiveness of Erivedge was evaluated in a single, multi-center clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma. The clinical study’s primary endpoint was objective response rate, or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment. Of the patients with metastatic disease receiving Erivedge, 30% experienced a partial response and 43% of patients with locally advanced disease experienced a complete or partial response.
Erivedge 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 Erivedge treatment.