The Hedgehog signaling pathway plays an important role in regulating proper growth and development in the early stages of life and becomes less active in adults. Abnormal Hedgehog signaling is implicated in more than 90 percent of BCC cases.
Erivedge is designed to selectively target the Hedgehog signaling pathway which is implicated in the development of certain types of cancer, including basal cell carcinoma.
Roche is developing Erivedge under a collaboration agreement with Curis. Erivedge was discovered by Genentech and jointly validated by Genentech and Curis through a series of preclinical studies. Through this collaboration, Genentech (U.S.), Roche (ex-U.S. excluding Japan) and Chugai Pharmaceuticals (Japan) are responsible for the clinical development and commercialization of Erivedge. Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialization of Erivedge.
In January 2012 Erivedge became the first licensed medicine for patients with advanced basal cell carcinoma when the U.S. Food and Drug Administration (FDA) approved it under the priority review program that provides for an expedited six-month review of drugs that offer major advances in treatment. Erivedge is approved in the U.S. for the treatment of adults with BCC that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
Erivedge has also received approval in Israel, Mexico and South Korea and the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a conditional approval of Erivedge (vismodegib) in Europe for the treatment of adult patients with symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy.
About the ERIVANCE BCC Study
The TGA approval is based on findings from the pivotal ERIVANCE BCC study which enrolled 104 advanced basal cell carcinoma adult patients (71 had locally advanced and 33 had metastatic disease) from 31 study centers in the US, Australia and Europe.