05 Jul FDA Upholds Denial of Avastin
Avastin is no longer FDA approved for breast cancer. This decision was upheld at a hearing last week. Eye patients, however, need not worry.
The Food and Drug Administration had removed its approval for Avastin for the treatment of breast cancer last December. A hearing last week (June, 2011) allowed Genentech and the drugs’ supporters, to voice their concerns about the removal of the drug.
- While the FDA has removed its approval for one type of cancer, the drug is not being removed from the market.
The FDA argues that bevacizumab (generic name) is not effective in treating breast cancer patients and, so, reversed its original decision. The counter argument claims that Avastin is effective, though in a minority of patients.
This anti-VEGF drug has become effective treatment for wet macular degeneration. Avastin, used for the treatment of a variety of cancers, has become the standard of care and is used my most retinal specialists for their patients.
Avastin Not Effective for Breast Cancer
The initial data indicated that bevacizumab, when given along with another drug, stymied the progression of the disease for 5-6 months compared to the other drug alone. Avastin was given quick approval for breast cancer.
Since then, re-investigation could not duplicate the results, yet the incidence of GI bleeding complications were notable. There was no evidence showing improved lifespan either.
The FDA upheld the decision.
What Does This Mean?
Removing an FDA approval only means that insurance companies are likely not to reimburse doctors and hospitals for the treatment. While treatment can theoretically still be performed, it would require that patients pay for it out-of-pocket. Thus, it is cost prohibitive in most cases.
Regardless of the FDA hearing, eye patients do not need to worry. Though the drug may no longer be available for patients with breast cancer, the drug will still be on the market for other treatments.
We should be able to continue using it as a first line treatment for wet macular degeneration. Avastin may have lost its FDA approval for the treatment of breast cancer, but this is different than a drug being removed from the market.
(By the way, I have wondered why the FDA could not have compromised, in that, as long as existing patients accept the risks, treatment could continue. Why not remove the FDA approval from this point forward?)