EMA extends Avastin breast cancer licence
pharmafile | July 1, 2011 | News story | Sales and Marketing | avastin, breast cancer, metastatic breast cancer
The EMA has extended the breast cancer licence for Roche’s Avastin after initially restricting the drug’s use.
The decision comes in the same week that advisers at the regulator’s US counterpart recommended stripping Avastin of its breast cancer indication after trial results pointed to an increase in adverse events.
Avastin’s European licence now allows its use in combination with either paclitaxel or Roche’s Xeloda (capecitabine) as a first line treatment for women with metastatic breast cancer.
The label extension was prompted by the late-stage RIBBON 1 trial that showed a significant increase in progression-free survival of 8.6 months for patients taking Avastin (bevacizumab) with Xeloda, compared to just 5.7 months for those who only received Xeloda.
Hal Barron, head of global product development at Roche, said: “The decision received from the European Commission supports our belief that Avastin provides a clinically meaningful benefit in combination with Xeloda.
“We are pleased with this outcome because it means that women with metastatic breast cancer and their physicians will now have an additional treatment option in Europe.”
Avastin was restricted to use with just paclitaxel in March this year after a 2009 report showed the drug had a ‘negative trend in overall survival’.
The decision prevented the drug’s use with another chemotherapy drug docetaxel, after EMA advisors decided that combination did not provide additional survival benefits compared with docetaxel on its own.
Earlier this week FDA advisers voted against letting Avastin keep its breast cancer indication, after a two-year follow up trial showed an increase in adverse events for patients using the drug.
The US committee was looking at Avastin in use with a number of chemotherapy agents and decided the risk/benefit ratio was not in the drug’s favour.
A final decision now rests with the FDA’s commissioner Hamburg, who will make give her verdict in the near future.
Ben Adams
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