Genentech requests an FDA hearing on Avastin-paclitaxel combo

12/27/2010 | American City Business Journals

The FDA's plan to repeal approval of Avastin for metastatic breast cancer prompted Genentech to push for a hearing on the use of the treatment in combination with chemotherapy drug paclitaxel. The biotech firm intends to present additional information to "include our view as to why a hearing is particularly warranted here given the two years of clinician and patient reliance on this important indication, along with the contrary views that the European Medicines Agency reached on the same data supporting the use" of Avastin with paclitaxel, said Michelle Rohrer, Genentech's vice president of regulatory affairs.

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