GENENTECH SUBMITS SBLA FOR ADJUVANT HERCEPTIN

Genentech has completed the submission of a supplemental biologics license application (sBLA) with the FDA for use of Herceptin (Trastuzumab) to treat early-stage, HER2-positive breast cancer.

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.