The Food and Drug Administration is defending its recent decision to withdraw approval of Avanstin for the treatment of breast cancer in the wake of growing Republican criticism that the decision is a first step toward government rationing.
Richard Pazdur, the FDA's top cancer-drug regulator, told The Wall Street Journal that the decision was not based on the drug's cost — $88,000 per patient per year — but rather with concerns with drug maker Genentech's studies of the drug's benefits. Avastin is still approved for the treatment of four other types of cancers.
Sen. David Vitter (R-La.) has called the decision "sickening" and said it was analogous to the government denying care because the patient's life "is not deemed valuable enough." Other Republicans have also criticized the decision, while cancer experts are split.
"We made the decision because the drug has a marginal effect on tumor growth in breast cancer and in light of Avastin's severe side effects, the risks outweigh the limited benefit," Pazdur told the Journal.
European authorities have not revoked Avastin's approval for breast cancer treatment but have recommended restricting its use so that's only used in conjunction with one type of chemotherapy, paclitaxel.