GENENTECH SUBMITS SBLA FOR NEW HERCEPTIN INDICATION
Genentech has submitted a supplemental biologics license application (sBLA) to the FDA for the use of Herceptin to treat early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Genentech has requested a priority review designation for the new indication that, if granted, requires the FDA to take action within six months, the firm said recently.
The sBLA submission is based on interim analysis of more than 3,000 patients with early-stage HER2-positive breast cancer enrolled in two Phase III trials. The analysis showed that the addition of Herceptin (trastuzumab) to standard adjuvant therapy reduced the risk of breast cancer recurrence -- the primary endpoint of the studies -- by 52 percent in women with the disease, compared to patients who received standard adjuvant therapy alone, Genentech said. After three years in the study, 13 percent of women treated with Herceptin plus chemotherapy experienced disease recurrence, compared to 25 percent of women treated with chemotherapy alone.
Herceptin received FDA approval in September 1998 for use in women who have metastatic breast cancer with tumors that overexpress the HER2 protein. The treatment is indicated for weekly administration, both as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy. Herceptin is marketed in the U.S. by Genentech, in Japan by Chugai, and internationally by Roche.