ZURICH (Reuters) Nov 09 - 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 follows approval in August for Roche's targeted drug Zelboraf (vemurafenib) for melanoma, 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 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 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 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 basal cell carcinoma.
Basal cell carcinoma 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, are not always treatable with surgery and there is currently no medical treatment available.
The confirmed FDA action date is March 8, 2012. Roche is also seeking approval for the drug in Europ
The news follows approval in August for Roche's targeted drug Zelboraf (vemurafenib) for melanoma, 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 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 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 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 basal cell carcinoma.
Basal cell carcinoma 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, are not always treatable with surgery and there is currently no medical treatment available.
The confirmed FDA action date is March 8, 2012. Roche is also seeking approval for the drug in Europ
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