FDA approves Genentech's Erivedge for treatment of BCC

GenentechJan 31 2012

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Erivedge^TM (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with a type of skin cancer, called basal cell carcinoma (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 is the first FDA-approved medicine for people with advanced forms of the most common skin cancer. It is a capsule that is taken orally once-a-day.

Basal cell carcinoma is generally considered curable if the cancer is restricted to a small area of the skin. However, in rare cases, lesions can become disfiguring and invade surrounding tissue (locally advanced) or spread to other parts of the body (metastasize). In these cases of advanced BCC, the disease cannot be effectively treated with surgery or radiation. Advanced BCC often results in severe deformity or loss of function of affected organs.

"Today's approval provides a new treatment for people with advanced basal cell carcinoma who, until now, had no approved medicines to help shrink disfiguring or potentially life-threatening lesions," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We are pleased that in the last six months we have been able to provide two new medicines for different types of advanced skin cancer to people who previously had few or no treatment options."

Erivedge will be available in the United States within one-to-two weeks of approval and will be distributed through specialty pharmacies. For more information about Erivedge distribution in the United States, doctors can contact Erivedge Access Solutions (http://www.ErivedgeAccessSolutions.com or 1-888-249-4918). Erivedge Access Solutions also provides doctors and patients coverage and reimbursement support, patient assistance and information resources.

Roche has also submitted a marketing authorization application (MAA) for Erivedge in the European Union (EU). In order to provide people with advanced BCC who live outside of the United States access to Erivedge while Roche pursues marketing authorization worldwide, the company is conducting a Phase II safety study in the EU and other countries that is enrolling patients with advanced BCC.