The Food and Drug Administration (FDA) is to consult outside experts on whether Avastin (bevacizumab) should be approved to treat breast cancer in the US.
The FDA reviewed data from the manufacturer Genentech and said patients on Avastin and chemotherapy have slower cancer progression, but do not survive longer overall than patients using chemotherapy alone.
The firm is asking the FDA to approve the drug alongside the chemotherapy drug Taxol (paclitaxel) for patients with advanced breast cancer who have not already taken other medications.
Avastin is currently approved for patients with specific types of lung and colon cancer. It was the company’s second best-selling product last year with revenues of $1.7bn.
But because of the uncertainty, the regulator will now ask a panel of cancer experts if the data is strong enough for it to approve the treatment.
The panel will weigh up the importance of the results, as well as some of the side-effects seen with Avastin, which include heart attacks, hypertension and blood clots.
The FDA is not legally required to follow the guidance of its panels, although it often does so.
An analyst from Stanford Group, Gregory Frykman, said the odds of a positive outcome for Genentech have dropped from 65% to 40% “based on conservative posturing by the agency”.
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