The FDA said Dec. 16 it planned to withdraw its OK for Avastin as a first-line treatment for metastatic HER2-negative breast cancer combined with paclitaxel. South San Francisco-based Genentech asked the FDA for a hearing on Dec. 23. Today’s submission includes all the evidence and data that Genentech plans to rely on in its arguments at the hearing, for which no date has yet been set.
Genentech, which is owned by Swiss giant F. Hoffman-La Roche Ltd., told the FDA that “a hearing is particularly warranted” because the drug has already been used for this treatment (the FDA approved it in early 2008) and because European regulators, who reviewed the same data, supported the use of Avastin in breast cancer.
“Since this approval, thousands of women with MBC have been treated with Avastin in the United States,” Genentech said.
For its part, the FDA looked at Avastin when it was later tested in combination with two other types of chemotherapy than paclitaxel. Avastin didn’t do as well in those tests as it did with paclitaxel. Genentech disagrees with the FDA’s interpretation of that data and those two tests.
“We look forward to the opportunity to present our views more fully on these important issues,” said Michelle Rohrer, Genentech’s vice president of regulatory affairs, in a letter to the FDA.
Until talks with the FDA are finished, the drug is still being used to treat breast cancer along with paclitaxel. Avastin isn’t used by patients who’ve already had chemotherapy.
The complete response to the FDA is posted on Genentech’s website.
