August 5, 2011 — Genentech has a new proposal for keeping its licensed indication for bevacizumab (Avastin) in breast cancer.
The US Food and Drug Administration (FDA) is in the process of revoking the license for this indication. A final decision on the issue is awaited from the FDA commissioner, but no date has been set.
The manufacturer has appealed the FDA move to revoke the license, but after the recent 2-day meeting, during which the company laid out all of its arguments, the FDA Oncology Drugs Advisory Committee voted unanimously against allowing the breast cancer indication to remain.
The new proposal appears to be a direct response to many of the concerns that were raised at that hearing. In what the company has described as a "middle-ground" proposal for keeping the indication, it has filed a posthearing summary, submitted to the FDA under Docket No. FDA-2010-N-0621.
"Two facts cannot be disputed in the wake of the hearing to withdraw [bevacizumab's] breast cancer indication," the company concludes in that document. "The approved treatment options for patients with metastatic disease are extremely limited, particularly for patients who face aggressive disease, and [bevacizumab] 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 of [bevacizumab] plus paclitaxel, subject to a confirmatory study and with revised labeling and risk communications that respond directly to the views" and concerns that have been expressed by the FDA, the company notes.
The manufacturer has proposed new labeling for the drug, with highlighted changes. In it, bevacizumab retains its indication for metastatic breast cancer, but the treatment is restricted to women with aggressive disease and the fewest treatment options (e.g., patients with aggressive hormone-receptor-positive breast cancer or triple-negative disease). In addition, the labeling would restrict bevacizumab to use with paclitaxel (as in the current indication, based on the best clinical trial data available), and would provide information about the "differing effects seen with other chemotherapies" (for which the clinical trial data are not as good). It would also contain "important safety considerations, including serious side effects," according to the company.
The proposal also suggests that this indication would be covered by a Risk Evaluation and Mitigation Strategy, which would involve the distribution of a medication guide to every physician and patient considering this treatment option.
The US Food and Drug Administration (FDA) is in the process of revoking the license for this indication. A final decision on the issue is awaited from the FDA commissioner, but no date has been set.
The manufacturer has appealed the FDA move to revoke the license, but after the recent 2-day meeting, during which the company laid out all of its arguments, the FDA Oncology Drugs Advisory Committee voted unanimously against allowing the breast cancer indication to remain.
The new proposal appears to be a direct response to many of the concerns that were raised at that hearing. In what the company has described as a "middle-ground" proposal for keeping the indication, it has filed a posthearing summary, submitted to the FDA under Docket No. FDA-2010-N-0621.
"Two facts cannot be disputed in the wake of the hearing to withdraw [bevacizumab's] breast cancer indication," the company concludes in that document. "The approved treatment options for patients with metastatic disease are extremely limited, particularly for patients who face aggressive disease, and [bevacizumab] 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 of [bevacizumab] plus paclitaxel, subject to a confirmatory study and with revised labeling and risk communications that respond directly to the views" and concerns that have been expressed by the FDA, the company notes.
The manufacturer has proposed new labeling for the drug, with highlighted changes. In it, bevacizumab retains its indication for metastatic breast cancer, but the treatment is restricted to women with aggressive disease and the fewest treatment options (e.g., patients with aggressive hormone-receptor-positive breast cancer or triple-negative disease). In addition, the labeling would restrict bevacizumab to use with paclitaxel (as in the current indication, based on the best clinical trial data available), and would provide information about the "differing effects seen with other chemotherapies" (for which the clinical trial data are not as good). It would also contain "important safety considerations, including serious side effects," according to the company.
The proposal also suggests that this indication would be covered by a Risk Evaluation and Mitigation Strategy, which would involve the distribution of a medication guide to every physician and patient considering this treatment option.
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