"Respectfully, that determination would be contrary to the most reasonable interpretation of the scientific data."
In addition to defending E2100, the summary shows that Genentech will focus on FDA’s application of the accelerated approval standard, the external support for Avastin’s use in MBC (including that of other regulatory bodies), and the agency’s potential regulatory flexibility.
In the end, it’s that flexibility that Genentech is really appealing to. "Regulatory flexibility is intended for cases like this," the summary concludes, "where a formulaic application of the withdrawal standard would deprive patients and physicians of the choice intended by the accelerated approval program – and do so in the face of continued findings of benefit, a well-understood safety profile, and a viable option for providing a clearer answer to the remaining scientific questions."
Internal Medicine News Digital Network and "The Pink Sheet" are published by Elsevier.