The dust hasn't settled from the FDA advisory panel vote on Avastin, and it doesn't look likely to settle soon. Even as Medicare officials announced they'd continue to cover Avastin for breast cancer--regardless of whether the FDA ends up pulling the indication--Republican lawmakers were criticizing agency's very attempt.
Indeed, House Republicans are promising to make Avastin an issue during next week's hearings on the reauthorization of FDA's user-fee funding provisions. House Energy and Commerce Committee Chairman Fred Upton says he has "grave" concerns about FDA's review of the data on Avastin, the Wall Street Journal reports, and aides are saying that either he or another member will raise those concerns at Thursday's hearing.
CDER Chief Janet Woodcock will be testifying at that hearing, and the WSJ's sources say she had better be ready to confront some difficult questions about the Avastin debate. Avastin won its breast cancer approval under the agency's fast-track program, which required Genentech to conduct follow-up studies to confirm preliminary data that supported that approval.
The follow-ups didn't deliver enough evidence of Avastin's benefit to breast cancer patients, at least not enough for the FDA, so the agency has moved to pull that indication. The advisory panel hearings and vote earlier this week were part of Genentech's appeal of that FDA move. Genentech is now wholly owned by Roche.
Meanwhile, CMS announced it would keep paying for breast cancer patients to be treated with Avastin, something that should allay the concerns of older women covered by the government program. Private insurers will have to make their own choices, of course, and off-label treatment is often spurned by those payers. But Medicare's coverage choice could influence private insurers to follow suit. And Genentech says its patient access program is going to continue to provide Avastin to women without insurance as well as those whose insurance companies stop covering the drug.
- read the WSJ piece
- check out the Reuters news