The CHMP stated, on the basis of quality, safety and efficacy data submitted, considers there to be a favorable benefit-to-risk balance for Erivedge and therefore recommended the granting of the marketing authorization. This marketing authorization is conditional, and will require the submission of additional data from ongoing studies. The CHMP grants conditional approval to medicinal products that fulfill an unmet medical need.
About Basal Cell Carcinoma (BCC) and the Hedgehog Pathway
Basal cell carcinoma is the most common type of skin cancer in Europe, Australia and the United States. The disease is generally considered curable if the cancer is restricted to a small area of the skin. In advanced BCC, if the disease is left untreated or recurs in the same location after surgery or radiotherapy, it may progress and spread further into surrounding areas such as sensory organs (ears, nose and eyes), bone or other tissues. Depending on the location of the lesion, some cases of advanced BCC can be disfiguring, and treatment with surgery or radiation can lead to the loss of sensory organs and their functions such as eyesight or hearing.
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, Inc. 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.