The brouhaha over Avastin as a breast cancer treatment is only intensifying. One cancer survivor has started an online petition asking the FDA to keep the breast cancer indication for the Roche drug--and has gathered 6,500 signatures, with the help of a video produced by her 19-year-old son. Another has an op-ed piece in today's Wall Street Journal.
This puts FDA in an even tougher spot than it faced when an advisory panel first voted to yank the indication, saying the drug's survival benefit is negligible and its side effects too troublesome. As BNet points out, anyone who argues against tossing every available high-tech drug at cancer patients is seen as heartless. Furthermore, critics immediately accused the agency of "rationing" healthcare when it raised the possibility of withdrawing the indication. These folks say it's Avastin's high cost, not its limited benefit, that the FDA cares about.
The problem is, Avastin does work well in some patients. But for others, it's not very effective. That two-month survival benefit cited by the advisory panel is an average, not an absolute. But unlike other targeted cancer drugs, which can be matched with the appropriate patients through diagnostic tests, Avastin has no clear biomarkers for success. Genentech (now owned by Roche) has been searching for possibilities for years now. If scientists had found a way to positively identify patients most likely to benefit from Avastin, it would be used by now.
- see the coverage at Pharmalot
- read the BNet post
- check out the WSJ column