Genentech Gets to Show Off Avastin Numbers

As I said above, anti-angiogenesis drugs have had a checkered history, and Avastin is no exception. Before this success, the drug failed a late-stage trial involving breast cancer patients. It's also had toxicity problems in studies involving lung cancer patients.

Fyfe says the strong data in the colon cancer study lends credence to the medical theory that says mucking up the formation of blood vessels in tumors is most effective when done earlier rather than later. This may explain why Avastin seems to prolong survival in front-line colon cancer patients, but was not effective in breast cancer patients who had already suffered through multiple relapses of their disease.

Fortunately for Genentech, drugs used in early cancer-fighting regimens are also more lucrative from a commercial perspective, which explains why people are so excited about Avastin's potential.

[Whether the Avastin data justifies Genentech's current stock price -- which some believe already prices in Avastin peak sales of $2 billion annually -- is a hot debate and one I examined in an earlier story.]

The next step for Genentech will be to gather the Avastin data and ready it for filing with the Food and Drug Administration. The company is hoping for Avastin approval by the end of the first quarter of next year, says Fyfe.

"This study fulfills all the regulatory requirements for approval," she says.

One challenge, however, will be to ramp up the Avastin manufacturing process to meet commercial demand. Genentech plans on transferring Avastin to its large-scale Vacaville, Calif. drug-manufacturing facility, from its current home in South San Francisco. This will require FDA approval.

As expected, Genentech also released data Sunday that expresses the Avastin survival benefit as a "hazard ratio" indicating a reduction in the relative risk of death between the two arms of the study.

The Avastin hazard ratio was in the range of 0.63 to 0.65, which means that colon cancer patients taking Avastin plus chemo have a 50% increase in their chance of survival compared to patients taking chemo alone. The study was powered to show a 33% increase in the chance of survival.