July 20th, 2010
06:55 AM ET

D-day for once-promising breast cancer drug?

A drug that got preliminary approval for treating breast cancer could see that approval reversed after an FDA meeting Tuesday, on the heels of two studies with discouraging results.

Bevacizumab, better known by its brand name, Avastin, was given what is known as “accelerated approval” in February 2008, after a study called E2100 showed that women taking the drug went longer without their symptoms getting worse. All the women had metastatic cancer, meaning the cancer had spread beyond the original tumor. The FDA approval came on the condition that Genentech, the drug’s manufacturer, conduct larger studies to confirm the treatment’s success.

The results of those studies – known as AVADO and RIBBON1, respectively – were a major disappointment. In both trials, patients on Avastin went longer before symptoms worsened, but it didn’t translate to better survival. In the end, patients on standard drug therapies actually lived longer. Researchers also noted more side effects in the Avastin group, including high blood pressure, fatigue and loss of white blood cells.

Tuesday, an FDA advisory panel will review the latest evidence. Back in 2008, the same panel voted 5-4 against provisional approval, but was overruled by higher-ups at the FDA.

Charlotte Arnold, a spokeswoman for Genentech, said the company is looking forward to the panel’s debate. “They’ll be looking at the totality of the data. We believe that when you look at the three studies [E2100, Avado and Ribbon-1], you see consistent and reliable improvement in PFS [progression-free survival.]”

All the women receiving Avastin had a subtype of cancer called HER2/neu negative breast cancer; the designation means their tumors don’t produce a certain protein, HER2. In each of the trials, patients treated with Avastin also got other chemotherapy drugs. That’s a common protocol for experimental cancer medicines, done to ensure that every patient receives at least the standard therapy. Arnold said the differing results in the various studies might be explained by the different drug regimens.

Avastin is a protein that works to prevent the formation of the blood vessels feeding cancer cells. Starved of blood, a tumor can’t grow. Avastin is already approved to treat certain types of lung cancer, colorectal cancer, kidney cancer and brain cancer. Those treatments will not be affected by Tuesday’s vote.

soundoff (3 Responses)
  1. Susan

    I was on one of the first trials of Avastin or Placebo and from the time of my very first scans I have shown amazing results. I have metastatic breast cancer and have had this since 2004. In 2006 I went on the study and have been stable ever since resuming a bormal life with absolutely no side effects at all. I am hoping absolutely hoping that my Avastin will not be taken off the market!

    July 20, 2010 at 14:34 | Report abuse | Reply
  2. LGLK

    I too am on the Avastin trial. I might be taken off the trial after almost a year on it due to side effects (protein in the urine). I am taking it in conjunction with Femara and I have seen great results. However, they don't know if it's the Avastin that's helping or if the Femara alone would have done the same. I guess this is the point of the panel today, to determine whether it helps in the long run. It is administered in conjunction with other pre-approved cancer meds as opposed to on its own. I've heard that some doctors are for it and others are skeptical of its benefits. If they can prove that it prolongs survival overall, they just might keep it.

    July 20, 2010 at 15:47 | Report abuse | Reply
  3. Mya

    PLEASE READ…. Man with 4 young babies fights for his life. See more at SaveStan. ORG

    July 20, 2010 at 23:25 | Report abuse | Reply

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