Avastin’s breast cancer use to continue in Europe
pharmafile | March 2, 2011 | News story | Sales and Marketing | CHMP, Cancer, European Commission, Roche, avastin, bevacizumab, breast cancer, docetaxel, paclitaxel
Roche’s Avastin will remain on the market as a treatment for breast cancer, but only in combination with paclitaxel, the European Commission has confirmed.
Avastin (bevacizumab) was under scrutiny after data Roche submitted in December 2009 to support extending its licence revealed a “negative trend in overall survival” among patients using the drug with taxanes, including paclitaxel and docetaxel.
The EC said it would follow advice from European regulators at the EMA to allow Avastin’s use in combination with paclitaxel, the most common chemotherapy used in Europe, to treat women with metastatic breast cancer.
But the drug can no longer be used with docetaxel after EMA advisors decided that combination did not provide additional survival benefits compared with docetaxel on its own.
Hal Barron, Roche’s chief medical officer and head of global product development, said: “We are pleased that the European Commission is continuing to support Avastin in combination with paclitaxel.
“This is important news for thousands of women living with incurable HER2-negative breast cancer in the European Union.”
The updated label is effective immediately and the changes to the European breast cancer label do not affect Avastin’s other approved uses in kidney, brain, lung and rectal cancers.
This decision is at odds with the FDA who decided in December to rescind Avastin’s licence for metastatic breast cancer after post-marketing studies showed no significant survival benefit and a “significant increase” in serious side effects.
To add weight to this decision recent trials completed in the US have shown an increase risk of heart failure for women using the drug.
Roche recently downgraded its forecast for its blockbuster drug from a potential $9 billion in sales for 2011 down to $7 billion given the problems it has endured with its breast cancer licence.
It suffered an additional blow in England last week when NICE recommended Avastin shouldn’t be used in breast cancer patients on the NHS as it was not deemed cost-effective.
Ben Adams
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