Published November 09, 2011
Roche's experimental skin cancer drug vismodegib has been given "priority review" status by U.S. authorities, the Swiss drugmaker said on Wednesday.
The news comes hot on the heels of approval in August for Roche's targeted drug Zelboraf for the deadliest form of skin cancer, which came two months ahead of schedule.
The Food and Drug Administration will now consider the use of vismodegib, another targeted medicine, to treat adults with advanced basal cell carcinoma—the most common type of skin cancer—for whom surgery is not thought to be an option.
The FDA says that the time it takes it to review a new drug application is reduced for a priority review, with the goal for completion being six months.
Vismodegib, a type of drug called a Hedgehog pathway inhibitor, showed "remarkable" results in a mid-stage trial, substantially shrinking tumors and lesions in patients with this potentially fatal type of skin cancer.
The Hedgehog signaling pathway is important in regulating proper cellular growth and development in the early stages of life and then becomes less active in adults. Mutations in the pathway that reactivate Hedgehog signaling are seen in several different types of cancer, including BCC.
Basal cell carcinoma is the most common type of skin cancer in Europe, Australia and the United States and there are about 2 million cases worldwide. It is usually treated with surgery and generally thought to be curable when the cancer is restricted to a small area of the skin.
But advanced cases of the disease, or those which have spread and led to secondary tumors, can weaken or disfigure sufferers and can ultimately be life-threatening. These cases are not always treatable with surgery and there is currently no medical treatment available.
Roche's partner, Curis, is eligible to receive milestone payments and royalties under a collaboration agreement on the drug.
The confirmed FDA action date is March 8, 2012. Roche is also seeking approval for the drug in Europe.