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news.The FDA has extended the review period for Genentech's supplemental biologics license application for Herceptin for the treatment of patients with early-stage, HER2-positive breast cancer.
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The FDA was expected to make a decision on the filing by August 17, 2006, but, having deemed the additional information recently requested for the application a major amendment, has now extended the review period for up to an additional 90 days.
The supplemental biologics license application (sBLA) submission is based on a planned joint interim analysis of more than 3,000 patients with early-stage HER2-positive breast cancer enrolled in two phase III trials.
In these randomized, controlled studies, patients received either Herceptin with paclitaxel chemotherapy or paclitaxel chemotherapy alone, following initial treatment with surgery and four cycles of anthracycline and cyclophosphamide (AC). The primary endpoint of the studies was disease free survival.
The interim analysis of 3,351 of the 5,635 women enrolled showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence by 52% compared to those who received chemotherapy alone. 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.
“We are committed to working with the FDA to complete this review and are confident that we will be able to finalize approval discussions quickly,” commented Hal Barron, SVP of development and chief medical officer at Genentech.