Avastin Use For Breast Cancer May Be Revoked
Dangerous drugs seem to have been rushed to market with F.D.A .approval during the early part of this century. Now, this seems to be changing. This week, advisory committee recommended that the F.D.A. revoke approval of the drug Avastin as a treatment for breast cancer.
This recommendation is stunning as Avastin is the world’s best-selling cancer drug, with global sales of about $6 billion last year.
Avastin, which is sold by Roche’s Genentech unit, will remain on the market even if the F.D.A. follows the committee’s advice, as it usually does. That is because Avastin is also permitted as a treatment for colon, lung, kidney and brain cancers. So even if the F.D.A. does take the rare move of rescinding its approval, doctors would still be able to use Avastin off-label for treatment of breast cancer.
While drug manufacturers are prohibited by law from selling and promoting drugs for non-approved purposes, doctors are not restricted in their use of drugs. This has led to many drug companies devising schemes to illegally promote drugs for off-label use.
Avastin was given so-called accelerated approval in early 2008, a way for the F.D.A. to approve drugs for life-threatening diseases based on less than complete evidence of effectiveness. Manufacturers must then do further studies to confirm the benefit of the drug.
The two new trials sponsored by Roche for this purpose showed a much smaller effect of the drug. The two studies, in which different chemotherapy drugs were used with Avastin, showed few signs that it could prolong lives. Use of Avastin did not prolong the women’s lives by a statistically significant amount, the gold standard for cancer drugs. And the drug had serious side effects for some patients.
The panel voted 12 to 1 to recommend the revocation. The data discussed at the meeting that for advanced breast cancer, the initial data that led to approval was not borne out by subsequent studies.
Even though doctors can still use Avastin for treatment of breast cancer, some insurance companies might be reluctant to pay for an unapproved use.
Avastin, also known as bevacizumab, is Roche’s best-selling product. Market analysts predict Roche might now lose about $500 million of the estimated $700 million in Avastin sales.
