Genentech has formally asked the FDA to overturn last month’s decision revoking the approval of the drug Avastin as a treatment for breast cancer. In the request, Genentech argues that the agency erred in interpreting the data about the drug and toughened its standards for approval without informing the company.
“The company requests a hearing because it believes women with this incurable disease are entitled to Avastin as an FDA-approved choice and because FDA’s proposed withdrawal raises broader implications for the development of cancer treatments that should be discussed in a public forum,’’ the company says in its 98-page request.
Pending the outcome of any hearing, Avastin retains its approval for breast cancer.
As Andrew Pollack writes in the New York Times, “The F.D.A. has not decided whether to grant a hearing. It seems likely to do so, however, given how controversial this matter is, even attracting the attention of members of Congress.”
