FDA Sends Genentech Drug to Panel

The Food and Drug Administration has requested a review panel for Genentech's(DNA Quote) application to get cancer drug Avastin approved for breast cancer, leaving observers surprised but optimistic.

The biotechnology company said Thursday that the Oncologic Drugs Advisory Committee panel will review in December its supplemental biologics license application (sBLA) for Avastin -- already approved for colon and lung cancer -- for metastatic breast cancer.

Genentech's sBLA, submitted in May 2006, is for Avastin in combination with paclitaxel chemotherapy for patients who haven't received chemotherapy for their metastatic breast cancer. The sBLA is based on a trial called E2100.

The company resubmitted the sBLA this August including an FDA-requested independent, blinded review of patient scans for progression-free survival, the primary endpoint. The company said it showed a similar magnitude of benefit to data presented in 2005.

Improvement in overall survival, the secondary endpoint, wasn't statistically significant. The speculation is that this may not be important, because once the breast-cancer patients progressed on the drug, other line of therapies were allowed that could have affected the data. Also, as Jefferies and Co. analysts pointed out in a report on Friday, E2100 placebo randomized patients were allowed to cross over and receive Avastin therapy -- which would affect the comparison of the placebo to the Avastin group.