FDA Will Speed Up Review of Roche Cancer Drug
From Associated Press (February 7, 2012)
NEW YORK -- Swiss drugmaker Roche said Tuesday that the Food and Drug Administration will make a decision on its experimental breast cancer drug pertuzumab by June.
Roche's Genentech business aid the FDA has accepted its application for marketing approval of pertuzumab and granted a six-month priority review. The agency is scheduled to make a decision on the drug by June 8.
Pertuzumab is designed to treat HER-2 positive breast cancer, an aggressive type of the disease that is less responsive to hormone treatment. Roche is asking the FDA to approve the drug for use against breast cancer that has not previously been treated. Pertuzumab would be used in combination with Herceptin, an older Roche drug.
In a late-stage clinical trial, patients who were treated with pertuzumab, Herceptin and chemotherapy lived six months longer than patients treated with Herceptin and chemotherapy alone, Roche said. Those patients had median survival of about 18.5 months, and their risk of death or disease worsening was cut by 38 percent.
Posted: February 2012