logo

Avastin no longer allowed for breast cancer

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).

Latest News from Pharma-Watch

FDA convenes to determine Fosamax bone fracture dangers

The New York Times Reports: In light of evidence linking the long-term use of Fosamax and femur fractures, the FDA said it plans to convene Friday to determine whether it will recommend suspending the use of the osteoporosis drug.

Spine Specialists Discredit Medtronic Bone Growth Product

June 29th, 2011 “It harms patients to have biased and corrupted research published…It harms patients to have unaccountable special interests permeate medical research,” read an excerpt from an

CT Brain Perfusion Scan Risks

The FDA released an advisory to consumers in October regarding the CT Bran Profusion Scan manufactured by GE. The advisory states that the scans default radiation therapy is set to high for most patient

Risk of death found in sleeping pill use -- Scripps

Scripps Study: Sleeping pills believed a cause of 500,000 premature deaths annually (March 1, 2012) Pick 10 people at random and ask them if they take sleeping pills. Chances are at least one of them

FDA pulls approval of Avastin breast cancer drug

Avastin no longer allowed for breast cancer The U.S. Food & Drug Administration has revoked its approval of Avastin after concluding the metastatic breast cancer treatment did nothing to control tumor