Unswayed by staff doubts about the evidence, an FDA advisory panel unanimously recommended Genentech's Avastin for fast-track approval for a particular brain cancer. Already approved for use against lung, breast and colon cancers, Avastin could get a quick OK for the new indication based on some promising new data.
As you know, FDA reviewers had been skeptical of imaging scans submitted to support the new use. The staffers said it's notoriously difficult to measure brain tumors using medical scans, so determining whether Avastin actually shrunk tumors would be equally difficult. But the committee figured that the study patients' response was clear enough to show a benefit. The images showed that 25.9 percent of patients in one study responded to Avastin treatment; in another, almost 20 percent responded.
As Genentech told the advisory panel yesterday, the patients with this type of brain cancer--glioblastoma--have few treatment alternatives, and the disease is nearly always fatal. Next, FDA higher-ups have to rule on the new Avastin use; the agency doesn't have to follow the committee's advice, but usually does.
- see the Genentech release
- read the Associated Press story
- check out the article in the New York Times