Genentech updates sBLA application for Herceptin in breast cancer at FDA's request

By Lisa Kerner

Charlotte, N.C., Aug. 11 - Genentech, Inc. said it provided additional requested information and analyses of previously submitted studies to the Food and Drug Administration as part of its supplemental Biologics License Application for Herceptin for the treatment of patients with early stage, HER2-positive breast cancer.

The FDA has extended the review period for the sBLA up to an additional 90 days beyond the Aug. 17 action date.

Genentech originally submitted the sBLA in February based on a planned joint interim analysis of more than 3,000 patients with early stage HER2-positive breast cancer enrolled in two phase 3 trials.

Patients received either Herceptin with paclitaxel chemotherapy or paclitaxel chemotherapy alone, following initial treatment with surgery and four cycles of anthracycline and cyclophosphamide.

Genentech said the primary endpoint of the studies was disease-free survival. 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, the company said.

"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," chief medical officer Hal Barron said in the release.

Genentech is a biotechnology company based in South San Francisco, Calif.

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