Study highlights Avastin heart failure risk
pharmafile | January 6, 2011 | News story | Research and Development, Sales and Marketing | Roche, avastin, bevacizumab, breast cancer
A new study confirms that Roche’s Avastin is linked to a small but significant increased risk of heart failure in patients with breast cancer.
The meta-analysis is the first comprehensive report to show Avastin (bevacizumab) increases the risk of significant heart failure in patients with breast cancer.
The findings add weight to the FDA move to withdraw the drug’s licence for use in metastatic breast cancer patients, which it confirmed in December.
The study published in the Journal of Clinical Oncology examined data from five clinical trials of patients with breast cancer taking Avastin.
Lead author Dr Toni Choueiri, attending physician, solid tumour oncology at the Dana-Farber Cancer Institute, examined data from 3,784 patients. The meta-analysis found 1.6% developed heart failure.
Dr Toni Choueiri told Reuters: “Overall, the risk is small, but it is definitely more than the placebo.”
Other side effects were more common – 25-30% of patients taking the drug developed high blood pressure, 5% of them severe hypertension, and about 4-5% developed blood clots.
The new analysis shows the relative risk was almost five times as high compared to placebo. No differences emerged between high and low doses of Avastin.
The FDA conducted its own review of data during 2010. It reached similar conclusions about the adverse events, but also found no evidence that the drug helped extend lives compared to existing treatments.
In July the Oncologic Drugs Advisory Committee voted that Avastin when added to standard chemotherapy, does not extend progression-free survival long enough to be clinically meaningful in patients with HER2-negative, metastatic breast cancer. In December the regulator confirmed it would withdrawal its approval in these patients.
Roche is challenging the decision, and wants a public hearing to be held about the regulator’s move.
Avastin is also approved for use in colorectal cancer, non-small cell lung cancer and renal cell carcinoma, and the study did not look at patients with these cancer types.
Brett Wells
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