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July 20th, 2010
05:13 PM ET

Panel: Revoke drug's use in breast cancer

A drug that raised hopes for treating metastic breast cancer was rejected by an FDA advisory panel Tuesday, after two trials that failed to show any improvement in survival.

If the FDA follows through on the guidance, it would reverse a 2008 decision that gave provisional approval to bevacizumab, better known by its brand-name, Avastin. That conditional approval was based on a study showing that women on Avastin went 52 percent longer without their symptoms getting worse. However, two larger followup studies found that women on Avastin did not live longer, and more of them suffered serious side effects, including high blood pressure, fatigue and loss of white blood cells.

The vote of the advisory panel Tuesday was 13-0 against making the conditional approval permanent. “We were all hoping the data from these new trials would extend the benefit,” said Dr. Gary Lyman, a breast cancer specialist and researcher at Duke University. “We were all disappointed.”

Avastin is a protein that works by preventing the formation of blood vessels that feed 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.

Lyman said he suspects the drug is helpful to some breast cancer patients, but that more research is needed to show which ones might benefit.

One prominent breast cancer specialist sharply criticized the vote. Dr. Kimberly Blackwell, also from Duke, said the recommendation – if upheld – would leave patients with few choices except for older chemotherapy drugs.

“The toxicity of our other available drugs is far worse,” Blackwell told CNN. “I think it’s a terribly unfortunate day for breast cancer. It’s devastating. I have more than 100 patients on the drug, and they’ve done well. I don’t know what I’m going to tell them.”

While doctors would still be allowed to prescribe Avastin, unless it’s specifically approved for breast cancer, insurers are unlikely to pay – putting the drug, and its price tag of tens of thousands of dollars per year, out of reach for all but the wealthiest patients.

Charlotte Arnold, a spokesman for Genentech, the company that makes Avastin, said the company would work with the FDA to try and convince the agency that the medication is still useful. “We believe Avastin should be an option for patients with this incurable disease.”

All the women receiving Avastin in the studies considered by the FDA review panel 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 in a phone interview that the differing results in the various studies might be explained by the different drug regimens. Blackwell’s interpretation is simply that patients taking two medications are more likely to suffer side effects, than patients on a single drug.


soundoff (16 Responses)
  1. Linda O

    How does this impact the thousands of people that are using this drug for retinal diseases and macular degeneration?

    July 21, 2010 at 09:02 | Report abuse | Reply
    • Guest

      FYI, Avastin is not indicated for macular degeneration. The product (while the same molecule) is Lucentis. And this should not have any impact on this entirely separate drug, separate indication which was not an accelerated approval.

      July 21, 2010 at 17:37 | Report abuse |
  2. Missy Dudley

    I had Inflammatory Breast Cancer Stage IIIB and I was administered Herceptin along with three other chemo drugs. I am currently prescribed arimadex. I have been in remission going on 6 years.

    July 21, 2010 at 09:29 | Report abuse | Reply
    • Pat-SJ

      Best wishes for many more years Missy!

      July 21, 2010 at 09:32 | Report abuse |
  3. Pat-SJ

    And what about women who's BC is HER2/neu positive?

    July 21, 2010 at 09:31 | Report abuse | Reply
    • Dori

      HER2 positive patients get a different drug. I'm a 7 year survivor of stage IV breast cancer and was on Herceptin for three years and have now been on Tykerb for the last three. Cancer is in remission. Main side effect is some fatigue and skin problems on my feet. It's tolerable. Grateful to be alive. The drug is very expensive though, like close to $4000 for a three week supply. Thank God for my husband's great health insurance!

      July 21, 2010 at 10:01 | Report abuse |
  4. Craig

    http://www.helpbustbreastcancer.com

    July 21, 2010 at 09:32 | Report abuse | Reply
  5. Anne L

    I participated in this trial and had a lot of side horrible effects. That said, unlike what the article above states, most women who were on the trial were taking more than 2 drugs... Adriamycin, Cytoxan and Taxol PLUS Avastin was a very standard protocol not t mention all of the side-effect drugs that patients are prescribed. It is very difficult to differientiate what is causing what... That said, I can accept this news but I hope all factors were taken into consideration and that this does not slow down medical advancements to fight breast cancer. I'm 31 and will be tracking this for the rest of my life.

    July 21, 2010 at 09:43 | Report abuse | Reply
    • cblack

      I am 43 yrs old and a survivor of triple negative breast cancer. I was on the protocol of Taxol, Doxil, & Cytoxan along with Avastin. Did have significant side effects that were pretty miserable, but I am in complete remission as of Feb 1 2010. Praise God!!!!

      July 21, 2010 at 21:21 | Report abuse |
  6. Chrisie S

    Avastin did absolutely nothing for my 43 year old brother who died from Stage III Breast Cancer other than make him totally miserable.

    July 21, 2010 at 10:37 | Report abuse | Reply
  7. Darlene Walkenhorst

    I am 44 years old with a husband and 2 young children. I just started on Taxol and Avastin. I haven't even completed one cycle yet. This is my lifeline. Didn't we learn not to jump to hasty conclusions with the Women's Health Initiative study with Estrogen. Keep studying this drug. You may have just screwed me out of a longer life....Will I get to see my 10 year old graduate from High School? Not at this rate...Thanks :(...You're killing me here....

    July 21, 2010 at 10:44 | Report abuse | Reply
    • Lori P

      Darlene,
      I am also taking Avastin. I am part of phase 3 clinical trial and am in the Avastin group. I don't know your situation, but is it possible for you to get into an Avastin trial?

      Personally, I have mixed feelings about Avastin. Do I want to take it if it doesn't work for breast cancer (which I don't think they know for sure yet. These studies were with metatstic breast cancer. There are studies going on with early breast cancer). There are other treatments that, while older, do work. But, I recognize that not all breast cancer is alike, and I don't know your particular situation.

      Good luck to you. I am sure you will be talking with your oncologist right away.

      July 21, 2010 at 11:11 | Report abuse |
    • LGLK

      Hi Darlene, I am also on a trial for Avastin (with Femara). Avastin is always used in conjuction with other drugs. The other drugs are the "lifeline" so to speak, and the Avastin may or may not enhance these meds. I think the point is, if the Avastin is taken away, would the Taxol, or in my case, Femara, work anyway? Yes. Would it extend survival? THAT's what they are asking, and they are saying that based on all these studies, the answer is no. I have mixed feelings about it. Data as a collective whole is one thing; individual cases is another. I don't know if it's helped me (oh I was definitely on it due to side effects, even though it was a blind study) or if it was Femara, or both together, but maybe in the long run it's added some time to my life. I'm on the fence. I agree though that they should not be rash and take it off the table for BC treatment. Honestly – think of all the other harsh chemo drugs out there where the side effects were worse. I was able to live my life normally and the side effects overall were very tolerable. So I hope that they are not jumping to conclusions too soon.

      July 21, 2010 at 17:16 | Report abuse |
  8. ONC NURSE

    I am an oncology nurse and we use a lot of Avastin. It seems to me from speaking to our patients, that the side effects from Avastin are minimal. It doesn't cause nausea, doesn't seem to affect blood counts and doesn't cause fatigue. Majority of our patients do not even receive premedications to prevent reactions. IIts a hard decision to make. On one hand, what do you have to lose in a patient that has no other options? On the other hand, why should we continue to spend the money and feed into these drug companies for a product that isn't giving the results desired. Maybe it should be up to the physician and be based on past experience with the drug. As far as side effects though, I would have to think long and hard about refusing this drug, based on the "terrible" side effects. I just have not seen or had patients to indicate this to me.

    July 21, 2010 at 21:07 | Report abuse | Reply
  9. holly

    what is there to lose? sounds like a lot of money for a drug that doesnt help

    July 21, 2010 at 21:54 | Report abuse | Reply
  10. Christi

    I have been on avastin since june 2008 for metastatic breast cancer with lung mets. Was on it from June thru Jan 09 with carboplatin and taxol. Those drugs obliterated my cancer. Since Feb 09 I have been on avastin alone. No BP issues, No serious issues at all except for fatigue and body aches....So much better than all those drugs together or any of the other treatments I have had. I have triple negative breast cancer and even starting at stage 2 with no lymph node involvement it took my cancer less than a year to spread to my right lung. With Avastin alone, I have remained with NO Evidence of Disease (NED) for 18 mos....I would say it is working and I have several other friends who are doing as good or better than me. Whose to say that quality of life isn't worth something..If this were your wife, sister or mom and it was the only drug she could take to keep her cancer in check would you want it ripped from her list of treatments because it didn't extend someone else' life "enough." And what Dr. Blackwell mentioned about not "knowing what she will tell them." Most of the patients on this drug don't have a clue its about to be pulled.....I have friends who go to Sloan Kettering, MD Anderson, Dana Farber, Tampa, Fl and Mobile clinics who have no idea....No MD has mentioned it to them and when they brought it up to their chemo nurses, the nurses didn't even know. Its really going to hit the fan come September 18th when they go to get their drug and they are told there is nothing we can give you, or you have to go back to some older, more toxic drug.........I just pray they come to their senses!!!!

    August 15, 2010 at 22:37 | Report abuse | Reply

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