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 enrolled in two phase III trials, sponsored by the National Cancer Institute.
The analysis showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52%, compared to those patients who received standard adjuvant therapy.
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. A survival analysis conducted after patients had been followed for a median of 24 months showed a 49% improvement in overall survival.
“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 Dr Susan Desmond-Hellmann, Genentech’s president, product development.