The US Food and Drug Administration (FDA) has approved the targeted therapy Erivedge™ (vismodegib) for the treatment basal cell carcinoma of the skin that has spread to other parts of the body or that is locally advanced and cannot be treated with surgery or radiation.
Basal cell carcinoma is the most commonly diagnosed type of skin cancer. Most cases can be treated with surgery or other types of local treatment and are not life-threatening, but the condition often occurs on the face and can be disfiguring. In the most severe cases, the cancer may be very large, may invade structures other than the skin, or may spread to other parts of the body. In these advanced cases, it may not be possible to surgically remove the cancer, and treatment options are limited.
Erivedge targets a specific biological pathway (the Hedgehog pathway) that is thought to play a role in more than 90% of cases of basal cell carcinoma. Taken orally, Erivedge inhibits the abnormal signaling in this pathway that contributes to cancer growth.
A study that contributed to the approval of Erivedge enrolled 104 adult patients with locally advanced or metastatic basal cell carcinoma. All study participants were treated with Erivedge. A reduction or elimination of detectable cancer was observed in 43% of patients with locally advanced basal cell carcinoma and 30% of patients with metastatic basal cell carcinoma.
Side effects of Erivedge include muscle spasms, hair loss, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, joint pain, vomiting, and changes in taste. Erivedge may cause severe birth defects or fetal death if taken during pregnancy.
Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma.
Reference: FDA News Release. FDA approves new treatment for most common type of skin cancer. January 30, 2012.