FDA Upholds Denial of Avastin

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?)

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  • John D.
    Posted at 04:19h, 09 July Reply

    Thanks for your periodical updates on the world of eye care, I am not aware of many eye specialists that take such an interest to communicate to patients and lurkers as you do. I found this sight because of my floaters and this site has shown me hope and the world of research for many eye diseases. After I get my eyes fixed I would like to get active in fund-raising and getting out the word for eye research. I am in contact with many big youtube stars who raise thousands for cancer and AIDS research. I hope to do the same for diseases of the eye.

    Thanks for your time to communicate with the public. I will be making my Appointment with you in Sept. or October.

    -John DiSerio

    • Randall V. Wong, M.D.
      Posted at 09:50h, 11 July Reply

      Dear John,

      Thanks for the kind words. Yes, I would hope that more docs would consider doing this…..the time is right and there are too many benefits for everyone!

      Look forward to your appointment.


  • GM Holmes
    Posted at 09:24h, 03 August Reply

    I have Type 2 diabetes and hypertension and have lost some vision over the years. My vision was going downhill in my left eye but after three injections by Dr. Wong of Avastin 2.5 MG and an Ozurdex injection, I believe I can see better than before I had the first Avastin injection!

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