The U.S. Food & Drug Administration has revoked its approval of Avastin after concluding the metastatic breast cancer treatment did nothing to control tumor growth or help patients live longer, but instead increased their risk of developing severe high blood pressure, hemorrhages and other serious side effects.
“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,” said FDA commissioner Margaret A. Hamburg.
The FDA’s action follows the unanimous June recommendation of an FDA advisory committee to revoke Avastin’s approval, which had been granted on a provisional basis using special procedures created in the early 1990s to quickly get new but unproven AIDS drugs greenlighted.
Avastin now holds the distinction of being one of but only a handful of medications to have been approved and subsequently revoked.
Ironically, the first clinical trial involving Avastin showed the drug had promise as a tumor growth-retardant when paired with paclitaxel (brand name: Taxol). This combination appeared to delay cancer progression for about 200 days. Trouble was, the marrying of Avastin and paclitaxel exposed patients to more side effects and failed to appreciably extend their life expectancy.
Later studies tested Avastin with other drugs. In these investigations, the delays in cancer progression were even shorter than with paclitaxel. Morever, there was no extension of life expectancy and no improvement in life quality.
Avastin is made by Genentech Co. The manufacturer announced it intends to conduct another clinical trial, with the hope that the results will help convince the FDA to r e-instate Avastin’s approval.
Even after having lost its approval as a breast cancer treatment, Avastin retains its proponents among oncologists. For example, a committee of breast-cancer specialists affiliated with the National Comprehensive Cancer Network – an organization of major cancer hospitals – asserted that the FDA should keep Avastin listed as an appropriate therapeutic option.
Meanwhile, the loss of approval for that particular use will not prevent Avastin from remaining available to treat other types of cancers. Consequently, doctors will remain free to use it for breast cancer, but only if they do so on an off-label basis.
That might not matter in the end if private insurers decide to stop paying for treatment with Avastin (as some already have done). The drug costs roughly $7,500 per month. At that price, few apart from the wealthy would be able to afford Avastin out of pocket. (The story is different for those covered under Medicare: the federally-funded payor says it intends to keep paying for Avastin as a breast cancer treatment).