Roche seeks compromise with FDA over Avastin
In a bid to salvage the breast cancer indication for Avastin, Roche’s Genentech unit has pitched to the FDA what it is calling a “middle-ground proposal” that would allow the drug to retain its indication and only for use with paclitaxel. The deal includes revised labeling in which Avastin would be recommended only for patients displaying “aggressive disease” and who have the fewest treatment options. Roche also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide, according to Pharmalot.
The move comes just a few weeks after the completion of a two-day FDA advisory committee hearing in which panelists voted 6-to-0 to pull the breast cancer indication for Avastin. The drug maker had appealed a decision last December by the agency to yank the indication, prompting a heated debate over the veracity of the FDA accelerated approval program.
In explaining their initial decision, the FDA cited results of clinical studies and determined the data indicate Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks.
But Avastin is important to Roche. Many oncologists may continue to turn to Avastin as a salve, given that the Medicare is likely to continue coverage and the National Cancer Comprehensive Network has maintained its endorsement but the drug maker stands to lose some $1 billion in annual sales if the FDA does pull the indication and doctors turn elsewhere for treatment.