GENENTECH PROVIDES MORE INFORMATION ON HERCEPTIN TO FDA

Genentech announced that the FDA has notified the company that additional information recently requested during the review of the supplemental biologics license application (sBLA) for Herceptin for the treatment of patients with early-stage, HER2-positive breast cancer has been deemed a major amendment. The information requested, additional analyses of previously submitted studies, has already been submitted to the agency. In accordance with FDA guidelines, the agency has extended the review period for the sBLA up to an additional 90 days beyond the Aug. 17 action date. The company submitted the application in February, and it was granted priority review status.

The sBLA submission is based on a planned joint interim analysis of more than 3,000 patients with early-stage (or cancer that has not spread beyond the breast and the associated lymph nodes), HER2-positive breast cancer enrolled in two Phase III trials. The two studies were sponsored by the National Cancer Institute, part of the National Institutes of Health.

In the studies patients received either Herceptin with paclitaxel chemotherapy or paclitaxel chemotherapy alone, following initial treatment with surgery and four cycles of anthracycline and cyclophosphamide. The primary endpoint was disease-free survival. The interim analysis of 3,351 of the 5,635 women enrolled showed that the addition of Herceptin to standard adjuvant therapy reduced the risk of breast cancer recurrence by 52 percent compared with those who received chemotherapy alone. After three years in the study, 13 percent of women treated with Herceptin plus chemotherapy experienced disease recurrence, compared with 25 percent of women treated with chemotherapy alone.