Genentech submits supplemental biologics license application for adjuvant Herceptin
Genentech has completed a submission for 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 completed a submission for 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.
The biotechnology company 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 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% in women with early-stage, HER2-positive breast cancer, compared with those patients who received standard adjuvant therapy alone.