FDAnews
www.fdanews.com/articles/97691-genentech-resubmits-sbla-for-avastin-in-breast-cancer

Genentech Resubmits sBLA for Avastin in Breast Cancer

August 27, 2007

Genentech resubmitted a supplemental Biologics License Application (sBLA) to the FDA for Avastin in combination with paclitaxel chemotherapy for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer, the company announced.

The resubmission is based on the pivotal Phase III trial E2100 and marks the beginning of a six-month review period by the FDA. Genentech received a complete response letter from the FDA in September 2006 requesting additional information from the trial, including an independent, blinded review of patient scans for progression-free survival, the primary endpoint of the trial, the company said.

The results of the independent review are consistent with the magnitude of benefit initially assessed by Eastern Cooperative Oncology Group trial investigators and presented at the 2005 annual meeting of the American Society of Clinical Oncology. Genentech said that no new safety signals emerged outside of those known to be associated with Avastin (bevacizumab).

Avastin is being studied worldwide in more than 300 clinical trials and in more than 20 different tumor types, including for its potential use in adjuvant (therapy given after surgery to help decrease the risk of cancer recurrence) and metastatic colorectal, renal cell (kidney), breast, pancreatic, nonsmall cell lung, prostate and ovarian cancers, according to Genentech.