An advisory panel to the US Food and Drug Administration (FDA) dealt a blow to the Swiss drug maker Roche today, voting 12-1 to revoke approval for the company’s blockbuster cancer drug Avastin (bevacizumab) for treating advanced forms of breast cancer.
The drug was given the nod for breast cancer two years ago under a special mechanism called ‘accelerated approval’. As a condition of approval, Roche was compelled to conduct follow-up clinical trials to test Avastin’s benefits alongside conventional chemotherapy. Two studies showed more side effects among women on the drug and no added survival benefit.
Given Avastin’s demonstrated risks of gastrointestinal perforations, bleeding and blood clots, the data “does not support this being effective” in treating advanced breast cancer, panel chairman Wyndham Wilson, the US National Cancer Institute’s head of lymphoma therapeutics section, told Reuters.
But the company defended the medicine. In a statement, Sandra Horning, global head of clinical Development for hematology/oncology for Roche’s Genentech, said: “We are disappointed by the committee’s recommendation and believe Avastin should be an option for women with this incurable disease.”
Despite the setback for breast cancer, Avastin does seem to be safe and effective for an advanced form of lung cancer. Researchers already showed in two different phase 3 studies that Avastin in combination with chemotherapy improved patient outcome for people with non-squamous non-small-cell lung cancer (NSCLC). Now, a so-called phase 4, post-approval study of more than 2,200 NSCLC patients across 40 countries taking the medication has turned up few adverse events, researchers reported today in The Lancet Oncology.
Avastin, which is approved for a range of cancers, had global sales of nearly $6 billion last year, with breast cancer accounting for about $1 billion of these sales. The drug has also proven effective in preventing vision loss in people with macular degeneration, although only a truncated — and more expensive — form of the drug called Lucentis is approved for the disease.
You can read more about the two drugs’ roles in treating visions loss in the June issue of Nature Medicine.
Image: Genentech/Roche