FDA Sends Genentech Drug to Panel

Avastin, which is already approved for colon and lung cancer, will be reviewed to treat metastatic breast cancer.
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The Food and Drug Administration has requested a review panel for

Genentech's

(DNA)

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.

Genentech said no new safety signals related to the treatment were observed. As to what the FDA may be concerned about, spokesperson Ed Lang said, "At this time they haven't indicated anything specific. But as we have been, we'll be in contact and we'll get a better sense of their questions."

The Jefferies and Co. analysts believe the ODAC panel will focus on three issues: the strength of the progression-free survival as a primary endpoint in the E2100 trial, the significance of the failed Avastin E2119 trial in late-stage metastatic breast cancer and the significance of the overall survival data from E2100. The FDA action date for the sBLA is Feb. 23, 2008.

"While the ODAC panel review of the E2100 data comes as a surprise and adds risk to the margin, we continue to expect Avastin approval by the February 23 PDUFA date," said the Jefferies analysts who maintained their rating and price target for the company despite the "incremental risk" inherent in the panel meeting.

Genentech shares gave up 55 cents, or 0.7%, to $78.03, in recent trading Friday.