Women's Health Weekly
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Breast Cancer Therapy
sBLA submitted for adjuvant Herceptin in early-stage HER2-positive breast cancer
March 16th, 2006
Genentech, Inc., (DNA) announced that the company completed the submission of a supplemental biologics license application (sBLA) with the U.S. Food & 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 6 months. The sBLA submission is based on a planned joint interim analysis of more than 3000 patients with early-stage (or cancer that has not spread beyond the breast and the associated lymph nodes), HER2-positive breast cancer enrolled in 2 phase...
Source: Women's Health Weekly (2006-03-16)
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