November 29, 2011 — Canadian health authorities have revoked the license for bevacizumab (Avastin, Genentech) in metastatic breast cancer, after the US Food and Drug Administration (FDA) recently rescinded approval in the United States.
Health Canada, after consultation with an expert advisory panel, concluded that the drug has not been shown to be safe and effective for this indication, echoing the conclusions reached 10 days ago by the FDA. The panel, which included oncologists scientists and breast cancer advocates, met in March and unanimously concluded that the potential harm of bevacizumab in this indication is "of such magnitude that the risks of the drug far outweigh potential benefits," and that, on the basis of current available evidence, there is no value in leaving the drug available as a treatment option.
Although both the United States and Canada have revoked the license for metastatic breast cancer, bevacizumab remains on the market and approved for other uses, including lung and colorectal cancers and glioblastoma.
However, the metastatic breast cancer indication remains approved in Europe, after the European Medicines Agency (EMA) reviewed exactly the same data that led the United States and Canada to their revoking decisions.
"It is very hard for me to understand how 2 different regulatory authorities — the FDA and the EMA — could come to 2 such very different decisions based on the same data," said Fatima Cardoso, MD, director of the breast cancer unit and breast cancer research program at the Champalimaud Cancer Center in Lisbon, Portugal. Dr. Cardoso was cochair of the committee that authored new guidelines on the treatment of advanced metastatic breast cancer (ABC1), which she said emphasize the need to follow agreed-upon treatment paths.
"This is very disturbing for patients, because it gives the message that anyone can do anything in advanced breast cancer. This is the message we want to change; we all need to apply the same strict rules," Dr. Cardoso told Medscape Medical News.
When the first data on bevacizumab in breast cancer came out, "there was too much hype about what this drug could do. Now, after many more studies, it is clear that there are benefits, but they are much smaller than we initially thought...and the major problem with this drug is the price. The amount of benefit that this drug provides is not worth the amount it costs. If it was less expensive, we could use it more often," Dr. Cardoso explained.
The new ABC1 guidelines recommend that bevacizumab be used only in cases where there is rapidly progressive disease that is very aggressive and symptomatic, she noted.
This is a small select group of patients, she noted. For patients who are not symptomatic, adding bevacizumab can decrease quality of life by adding adverse effects without prolonging survival.
Dr. Cardoso emphasized the need for more research into biomarkers to identify patients who could benefit from bevacizumab. "Some patients benefit from this drug — we just don't know who," she said.
The manufacturer has pledged to continue research into biomarkers.
After the FDA announcement, Genentech said in a press release that it plans to launch a new phase 3 clinical trial of the drug in combination with paclitaxel in patients with previously untreated metastatic breast cancer, and evaluate a potential biomarker that "may help identify which people might derive a more substantial benefit from [bevacizumab]." In response, the FDA said it would welcome a new application from Genentech with data showing that bevacizumab clearly benefits a subset of patients with metastatic breast cancer.
Health Canada, after consultation with an expert advisory panel, concluded that the drug has not been shown to be safe and effective for this indication, echoing the conclusions reached 10 days ago by the FDA. The panel, which included oncologists scientists and breast cancer advocates, met in March and unanimously concluded that the potential harm of bevacizumab in this indication is "of such magnitude that the risks of the drug far outweigh potential benefits," and that, on the basis of current available evidence, there is no value in leaving the drug available as a treatment option.
Although both the United States and Canada have revoked the license for metastatic breast cancer, bevacizumab remains on the market and approved for other uses, including lung and colorectal cancers and glioblastoma.
However, the metastatic breast cancer indication remains approved in Europe, after the European Medicines Agency (EMA) reviewed exactly the same data that led the United States and Canada to their revoking decisions.
"It is very hard for me to understand how 2 different regulatory authorities — the FDA and the EMA — could come to 2 such very different decisions based on the same data," said Fatima Cardoso, MD, director of the breast cancer unit and breast cancer research program at the Champalimaud Cancer Center in Lisbon, Portugal. Dr. Cardoso was cochair of the committee that authored new guidelines on the treatment of advanced metastatic breast cancer (ABC1), which she said emphasize the need to follow agreed-upon treatment paths.
"This is very disturbing for patients, because it gives the message that anyone can do anything in advanced breast cancer. This is the message we want to change; we all need to apply the same strict rules," Dr. Cardoso told Medscape Medical News.
When the first data on bevacizumab in breast cancer came out, "there was too much hype about what this drug could do. Now, after many more studies, it is clear that there are benefits, but they are much smaller than we initially thought...and the major problem with this drug is the price. The amount of benefit that this drug provides is not worth the amount it costs. If it was less expensive, we could use it more often," Dr. Cardoso explained.
The new ABC1 guidelines recommend that bevacizumab be used only in cases where there is rapidly progressive disease that is very aggressive and symptomatic, she noted.
This is a small select group of patients, she noted. For patients who are not symptomatic, adding bevacizumab can decrease quality of life by adding adverse effects without prolonging survival.
Dr. Cardoso emphasized the need for more research into biomarkers to identify patients who could benefit from bevacizumab. "Some patients benefit from this drug — we just don't know who," she said.
The manufacturer has pledged to continue research into biomarkers.
After the FDA announcement, Genentech said in a press release that it plans to launch a new phase 3 clinical trial of the drug in combination with paclitaxel in patients with previously untreated metastatic breast cancer, and evaluate a potential biomarker that "may help identify which people might derive a more substantial benefit from [bevacizumab]." In response, the FDA said it would welcome a new application from Genentech with data showing that bevacizumab clearly benefits a subset of patients with metastatic breast cancer.
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