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Roche Builds Off Oncology Foundation With Autoimmune, Metabolic “Pillars”

Executive Summary

Roche views its autoimmune and metabolic disease programs as additional "therapeutic pillars" that will complement its existing strength in oncology

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ODAC Split On Avastin Use In First-Line Metastatic Breast Cancer

FDA's Oncologic Drugs Advisory Committee creates a second obstacle to the approval of Genentech's Avastin in metastatic breast cancer by deciding that existing data do not establish a positive risk-benefit profile for a first-line indication. Genentech's primary obstacle is relying on a surrogate endpoint for full approval, in trying to use progression-free survival as a direct measure of clinical benefit

ODAC Split On Avastin Use In First-Line Metastatic Breast Cancer

FDA's Oncologic Drugs Advisory Committee creates a second obstacle to the approval of Genentech's Avastin in metastatic breast cancer by deciding that existing data do not establish a positive risk-benefit profile for a first-line indication. Genentech's primary obstacle is relying on a surrogate endpoint for full approval, in trying to use progression-free survival as a direct measure of clinical benefit

Avastin resubmission

Genentech appears on target for a February user fee date on its resubmitted sBLA for Avastin (bevacizumab) as a first-line treatment for metastatic breast cancer in combination with paclitaxel. The firm announced the resubmission Aug. 24 and expects a six-month review. FDA requested an independent review of patient scans for progression-free survival in a "complete response" letter it sent to the firm Sept. 8 (1"The Pink Sheet" Oct. 2, 2006, p. 21). Genentech said the independent review results were consistent with its earlier positive findings...

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