Roche to challenge FDA on Avastin
pharmafile | December 21, 2010 | News story | Sales and Marketing | EMA, FDA, Roche, avastin, bevacizumab, breast cancer
Roche is set to challenge the decision by the FDA to remove a breast cancer indication from its blockbuster drug Avastin.
The US regulator had been contemplating withdrawing the drug’s licence for metastatic HER2-negative breast cancer after it failed to show a positive risk/benefit ratio in phase IV data presented in July.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said none of the phase IV studies showed that patients receiving Avastin lived longer and, more seriously, they did show patients receiving the drug experienced a “significant increase” in serious side effects.
Roche said it would not withdraw the indication voluntarily, which will allow it to exploit a little-used protocol that allows a public hearing in order to challenge the regulator’s decision.
Hal Barron chief medical officer and head of global product development at Roche, said: “We believe women living in the United States with metastatic HER2-negative breast cancer should […] have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA.”
Until the conclusion of these proceedings, Avastin (bevacizumab) remains FDA-approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer.
Avastin’s other indications in the US for lung, brain, kidney and rectal cancer are unaffected by this decision.
Avastin’s indication for breast cancer, in combination with chemotherapy agent paclitaxel, was approved in February 2008, but its availability on the market was contingent upon positive phase IV results.
Avastin’s European use restricted
Meanwhile, the EMA has said in a separate decision that Avastin can only be used with paclitaxel after it demonstrated prolonged progression-free survival.
The Agency did not go as far as its American counterpart and withdraw its indication completely, but its advisors at the CHMP did recognise that the risk/benefit ratio of Avastin in combination with chemotherapy agent docetaxel should “no longer be used in the treatment of breast cancer”.
The Agency also refused to expand Avastin’s breast cancer license to allow its use in combination with capecitabine given the “high risk” and “modest benefits” shown in recent data.
Barron said: “We are pleased that the EMA has confirmed the benefits of Avastin in combination with paclitaxel and that Avastin will continue to be available for women with metastatic breast cancer living within the European Union.”
The Agency said a European Commission decision on this opinion will be issued in “due course”, but added that the CHMP opinion does not affect the other approved uses of Avastin in the EU for advanced colorectal, kidney and lung cancer.
Avastin made $1 billion from its breast cancer indication only last year, around a fifth of the drug’s total revenue.
Ben Adams
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