It's official: Roche's Genentech has appealed the FDA's decision to revoke Avastin's breast-cancer indication. The company asked for an opportunity to state its case once again and filed a mound of evidence in support of its request for a hearing. "The company...believes women with this incurable disease are entitled to Avastin," Genentech's petition states, according to the New York Times.
One pillar of Genentech's Avastin defense is a claim the FDA misinterpreted the data on Avastin's usefulness as a breast-cancer treatment. The company cites the differences in outcome when Avastin was combined with Taxol--as it was in the first trial that won "fast-track" approval for the breast cancer indication--compared with other chemotherapy drugs, as it was in two follow-up trials. Genentech's FDA submission includes a data analysis designed to support that argument.
Genentech also will attack the FDA's decision on legal grounds; its petition says that withdrawing the breast-cancer indication "is inconsistent with the accelerated approval system" and that the follow-up studies met the FDA's own rules for affirming the original approval.
It's hard to imagine that FDA would deny this request, given its pledge that Medicare wouldn't change reimbursement rules until after the company had a chance to appeal. Not to mention the outcry from politicians and patients. But Genentech has added another impetus: "FDA's proposed withdrawal raises broader implications for the development of cancer treatments that should be discussed in a public forum," its petition states. How much benefit is enough for a cancer drug to clear the bar? Unfortunately, FDA can't consider cost in its approval decisions. We'd like to see a public conversation about the cost of cancer treatment, too.
- read the NYT blog post
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