The FDA has approved the first treatment for basal cell carcinoma, the most common form of skin cancer.
Vismodegib (Erivedge, Genentech Inc.), a hedgehog pathway inhibitor, received indications for treatment of metastatic disease and for locally advanced disease in patients who are not candidates for radiation therapy or surgery.
Perceived as a major therapeutic advance, health officials approved vismodegib within an expedited six-month window using the FDA’s priority review program. The drug received approval ahead of the March 8, 2012 prescription user fee goal date.
“Our understanding of molecular pathways involved in cancer, such as the hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” Richard Pazdur, MD, head of the FDA’s office of hematology and oncology drugs, said in a press release. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly.”
The approval came after data from a single multicenter trial involving 104 patients with basal cell carcinoma showed that 30% of patients who had metastatic disease experienced partial response to treatment and 43% of patients with locally advanced disease experienced complete or partial response.
More than 10% of patients experienced drug-related adverse events, including muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distortion or loss of taste, decreased appetite, constipation and vomiting.
Vismodegib is expected to be available in 150 mg oral daily doses at specialty pharmacies within two weeks, according to a press release from manufacturer Genentech.
The drug will contain a boxed warning due to the potential risk for death or severe birth effects in fetuses exposed to vismodegib. Clinicians should verify pregnancy status prior to initiating vismodegib, counsel pregnant women about the potential risks to the embryo/fetus and advise nonpregnant women on available types of highly effective contraception for use during treatment until seven months after the last vismodegib dose, the FDA advised.
Men prescribed vismodegib should be counseled to use condoms with spermicide during treatment until two months after the last dose to insure that an embryo/fetus is not exposed to semen containing vismodegib.