Genentech Inc. has completed the submission of a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for use of Herceptin (trastuzumab) to treat early-stage, HER2-positive breast cancer. Genentech has requested a priority review designation from the FDA, which if granted, requires the FDA to take action on the application within six months.
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 (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG), in collaboration with the Cancer and Leukaemia Group B, the Eastern Cooperative Oncology Group and the Southwest Oncology Group.
The primary endpoint (disease-free survival) results demonstrated that the benefit of adding Herceptin to chemotherapy in all clinically important patient subgroups studied, including age, hormone receptor status, tumour size, number of positive nodes, and the cooperative group protocol by which each patient was treated, was consistent with the benefit seen in the overall population.
"The two US cooperative groups and the lead investigators made the joint analysis of these phase III results possible. Their efforts involved an unprecedented level of collaboration, which ultimately allowed for these important results to be available for physicians and patients much earlier than had the trials continued on separate paths," said Susan Desmond-Hellmann, Genentech's president, product development.
Herceptin is a targeted therapeutic antibody treatment for women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, an especially aggressive form of the disease that affects approximately one-fourth of women with breast cancer. 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 tumours 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.
According to the American Cancer Society, an estimated 211,240 women were diagnosed with breast cancer and approximately 40,000 women died of the disease in the United States in 2005. Breast cancer is the most common cause of cancer among women in the United States and a woman is diagnosed with breast cancer in the United States every three minutes.