FDA advisers reject Avastin appeal
pharmafile | June 30, 2011 | News story | Sales and Marketing | FDA, avastin
An FDA advisory panel has refused to back Roche’s Avastin in advanced breast cancer after ruling it neither safe nor clinically beneficial.
The FDA’s commissioner Margaret Hamburg will make a final decision on Avastin’s breast cancer licence next month, but stressed any judgment on Avastin’s licence in metastatic breast cancer would not affect its other indications in kidney, colon, brain, and lung cancers.
The panel was meeting at a special two-day meeting in the US to decide whether the revocation of Avastin’s (bevacizumab) licence in breast cancer last year should remain in place.
The US regulatory authority had approved Avastin with a chemotherapy regimen under an accelerated programme in 2008, but required a two-year follow up study to prove its long-term efficacy.
When this data was released to the FDA last year it failed to demonstrate a statistically significant increase in survival, and even showed an increase in serious adverse events.
Based on this new data the US regulator pulled Avastin’s licence in metastatic breast cancer in December, but in a rare move Roche challenged the FDA’s decision.
Roche’s challenge led to this week’s debate on the drug, which prompted emotional scenes from patients, both those for and against Avastin’s use in breast cancer, and advocates of the drug broke down in tears when the panel’s decision was given.
If commissioner Hamburg does revoke Avastins’s breast cancer licence – as she is widely expected to do – Roche stands to lose around $1 billion in sales from its total $6 billion revenue from the drug, although the Swiss major has already planned for this eventuality.
Hal Barron, head of global product development at Roche, said: “We are very disappointed by the committee’s recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options.
“We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin,” he added.
The company said it would still conduct follow-up studies to confirm Avastin’s efficacy, regardless of the FDA’s decision.
Ben Adams
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