Genentech Resubmits sBLA for Avastin in Breast Cancer

August 31, 2007

Genentech resubmitted its supplemental biologics license application (sBLA) to the FDA for the use of Avastin in combination with paclitaxel chemotherapy as a first-line treatment for metastatic breast cancer, the company announced last week.

The submission addresses concerns the agency had with the filing when it issued a complete response letter for the sBLA last year. Genentech said that in the FDA’s complete response letter, the agency requested the company conduct a blinded, independent review of patient scans, which are used to assess progression-free survival, the primary endpoint of the study.

Genentech said that the data included in the original sBLA were generated from a clinical study conducted by the Eastern Cooperative Oncology Group (ECOG), which is primarily funded by the National Cancer Institute. Independent reviews of patient scans were not done by ECOG, in contrast to standard practice for company-sponsored clinical trials. The resubmission included the requested reviews, as well as an updated assessment of safety data.

The estimated FDA action data for the sBLA is in mid to late January 2008. The proposed indication covers treatment of patients with breast cancer tumors that test negative for human epidermal growth factor receptor 2, Genentech said.