Genentech seeks FDA OK for use of Herceptin in early stage HER2-positive breast cancer

By Angela McDaniels

Seattle, Feb. 15 - Genentech Inc. said it has completed the submission of a supplemental Biologics License Application with the Food and Drug Administration for use of Herceptin (trastuzumab) to treat early stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Genentech has requested a priority review designation from the FDA that, if granted, requires the FDA to take action on the application within six months.

The application is based on a planned joint interim analysis of more than 3,000 patients with early stage, HER2-positive breast cancer enrolled in two randomized, placebo-controlled phase 3 trials, which were sponsored by the National Cancer Institute.

The analysis showed that the addition of Herceptin to standard adjuvant therapy reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52% compared to those patients who received standard adjuvant therapy alone, the company said.

After three years in the study, 13% of women treated with Herceptin plus chemotherapy experienced disease recurrence, compared to 25% of women treated with chemotherapy alone.

Genentech said a survival analysis conducted after patients had been followed for a median of 24 months showed a 49% improvement in overall survival.

Herceptin is a targeted therapeutic antibody treatment for women with HER2-positive metastatic breast cancer, an especially aggressive form of the disease that affects roughly one quarter of women with breast cancer, the company said. Special testing is required to identify women who have HER2-positive breast cancer and who may be candidates for treatment with Herceptin.

Herceptin received FDA approval in September 1998 for use in women with metastatic breast cancer who have tumors that overexpress the HER2 protein. It is indicated for weekly treatment of patients 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 United States by Genentech, in Japan by Chugai and internationally by Roche.

Genentech is a South San Francisco biotechnology company.

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