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 (OTCQX:RHHBY) also suggests a Risk Evaluation and Mitigation Strategy, or REMS, as well as a Medication Guide.
The move comes just a few weeks after the completion of an extraordinary, 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 (see here and here).
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. These include severe high blood pressure; bleeding and hemorrhaging; development of perforations in the body, including in the nose, stomach, and intestines; swelling of the brain, and heart attack or heart failure.
But Avastin is important to Roche. Many oncologists may continue to turn to Avastin as a salve, given that Medicare is likely to continue coverage and the National Cancer Comprehensive Network has maintained its endorsement (read this, this and this), 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.
“Retaining accelerated approval will allow Avastin to remain available to the patients who have the greatest unmet need, while Genentech addresses (FDA) views regarding Avastin in metastatic breast cancer by: (1) conducting a confirmatory trial of Avastin with weekly paclitaxel’ (2) adopting labeling to direct doctors to the most appropriate MBC cases; and (3) undertaking further physician and patient communications to emphasize the efficacy and safety data, thus supporting informed decision making regarding Avastin,” the drug maker writes in its 133-page proposal.
“Two facts cannot be disputed in the wake of the hearing to withdraw Avastin’s breast cancer indication: the approved treatment options for patients with metastatic breast cancer are extremely limited, particularly for patients who face aggressive disease; and Avastin in combination with weekly paclitaxel indisputably has an effect on this form of breast cancer. These facts drive Genentech’s proposal to retain accelerated approval for Avastin plus paclitaxel, subject to a confirmatory study and with revised labeling and risk communications that respond directly to the views CDER has expressed regarding Avastin,” Roche concludes (read the complete proposal here).