The drug, known by its generic name vismodegib, will be sold under the brand name Erivedge and will be marketed in the US by Roche's Genentech. Another company involved in the development of the drug, Curis, will receive royalties.
Erivedge is a pill and works by inhibiting something called the hedgehog signaling pathway that is involved with the proper development of an embryo. The pathway becomes less active in adults.
Research has suggested that when the hedgehog pathway malfunctions, it can lead to the development of basal cell skin cancer and other types of cancer.
Erivedge is meant 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, a condition known as metastatic cancer.
The FDA said Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma. Basal cell carcinoma is the most common type of cancer in the US. It starts in the top layer of skin and is for the most part curable if detected and treated when the cancerous lesions are small.
The drug's approval was based on a study involving 96 patients with locally advanced or metastatic basal cell carcinoma. The study showed tumors shrank in 43 percent, or 27 out of 63, of patients with locally advanced basal cell cancer. About 30 percent of patients, or 10 out of 33, with metastatic cancer responded to the drug.