Roche/Genentech appeal FDA decision on Avastin for breast cancer; positive results with melanoma drug

US biotech firm Genentech, a wholly-owned subsidiary of Swiss drug major Roche (ROG: VX) yesterday submitted its response to the US Food and Drug Administration's proposal to withdraw approval of the metastatic breast cancer (mBC) indication for Avastin (bevacizumab; The Pharma Letter December 17, 2010).

The response explains Genentech's right to a hearing to allow full and fair discussion of the issues in a public forum, and sets forth the data, analyses and information on which Genentech intends to rely at a hearing to demonstrate why Avastin should remain an FDA-approved option for women in the USA with HER2-negative mBC.

In its assessment last year, the FDA said that, based on the results of four clinical studies of Avastin in women with breast cancer, the data indicated that it does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach and intestines; and heart attack or heart failure, the agency noted.