The US and Drug Administration has revoked approval of Roche's Avastin as a treatment for breast cancer, bringing to an end a long battle between drugmaker and regulator.
In July, the agency’s Oncologic Drugs Advisory Committee (ODAC) voted 12-1 in July 2010 to remove the breast cancer indication for Avastin (bevacizumab) in combination with paclitaxel, which got the green light in February 2008 under the FDA’s accelerated approval programme. Roche's Genentech unit appealed the decision but after a two-day hearing in June, the ODAC voted 6-0 that Avastin is ineffective for first-line HER2-negative metastatic breast cancer and in another unanimous vote said the drug has not been shown to be safe.
It therefore came as no great surprise when FDA Commissioner Margaret Hamburg confirmed in a 69-page opinion that she was revoking the agency’s approval in the breast cancer indication. It will still remain on the market for certain types of colon, lung, kidney and brain cancer.
She said “this was a difficult decision" and the FDA "recognises how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments". Nevertheless, Dr Hamburg noted that after reviewing the available studies "it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks".
She went on to say that nor is there evidence that Avastin will either help these women live longer or improve their quality of life. The risks include severe high blood pressure, bleeding and haemorrhaging, heart attack or heart failure and perforations in different parts of the body such as the nose, stomach, and intestines.
Dr Hamburg concluded by saying “I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”
New Phase III trial
Roche chief medical officer Hal Barron said “we are disappointed with the outcome", adding that the firm will "continue to provide help through our patient support programmes to those who may be facing obstacles to receiving their treatment in the USA". Despite the FDA's move, he declared that Roche will start a new Phase III study of Avastin in combination with paclitaxel in previously-untreated metastatic breast cancer "and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin".
Whether or not Aastin should have remained approved for breast cancer has stirred up huge debate. Medicare will continue to cover off-label use for breast cancer for the timebeing but is evaluating coverage, as are private insurers. Treatment could cost up to $100,000 a year.
Some patient organisations expressed disappointment but the National Breast Cancer Coalition applauded the FDA and Dr Hamburg. "If meaningful benefit for patients cannot be established, approval must not be granted [and] if evidence shows an approved drug has little or no benefit and harms patients, approval must be revoked", the group stated.