UPDATE: FDA Votes Down Avastin For Breast Cancer

UPDATE:

A Food and Drug Administration panel voted today to revoke Avastin's approval for treatment of breast cancer.

The panel voted 6-0 to remove the breast cancer indication from the drug, the Wall Street Journal reported.

Avastin, the best-selling cancer drug in the world, had been the subject of FDA meetings over the last two days.

The drug's benefits weren't deemed to outweigh its dangerous side effects, USA Today reported.

* * * * *

What will be the fate of Avastin?

That's the question the Food and Drug Administration will answer after two days of meetings. The government agency will decide whether or not to eliminate approval of the drug as a treatment for breast cancer.

Breast cancer patients testified in support of the drug today, appealing the FDA not to act on its December proposal to remove the drug's breast cancer indication. Avastin is manufactured by the Swiss drugmaker Roche, and is approved for metastasized breast cancer (advanced breast cancer that has already spread to other parts of the body).

"I am alive today due to Avastin," breast-cancer survivor Patricia Howard said at the hearing, Reuters reported.

This isn't the first time there's been an FDA panel vote to decide whether Avastin should be used to treat breast cancer. Last year, a panel voted to withdraw approval for the drug to treat advanced breast cancer because studies showed it didn't help patients live longer, CNN reported.

There were also side effects of the drug, including internal bleeding, holes in the stomach and high blood pressure, that prompted the Center for Drug Evaluation and Research (part of the FDA) to propose removing Avastin's breast cancer indication, CNN said.

But Avastin-maker Genentech, a unit of Roche, appealed that recommendation, and will make its case for the breast cancer indication at this week's meetings, Bloomberg reported.

Avastin was initially granted approval to treat breast cancer in 2008 because it demonstrated in studies its ability to slow advanced breast cancer tumor growth, when combined with chemotherapy, for more than five months.

But follow-up studies showed that the benefit was actually more like one to three months, and breast cancer patients were not living any longer than if they didn't take the drug. Genentech said even those few months are meaningful to advanced cancer patients, however.

Despite the FDA's decision this week, the drug is still approved to treat brain, kidney, lung and colon cancers. Technically the drug could still be used to treat breast cancer even if the FDA rules against it, but insurers would likely no longer cover it.

Comments

[Vermilionphoenix]

11:02 AM on 06/30/2011

I used to work for this company before I left to pursue an advanced degree. They paid me really well for only having a bachelor's degree, had fantastic parties (including concerts by performer's like Elton John, Matchbox 20, Mary J. Blige, Black Eyed Peas, Bob Dylan, . . . . I was intending to go back, but once I left I realized they could afford to do this by charging people desperate to live $1,000's for treatment. I think the FDA did the right thing here. I think Genentech wanted to the drug approved mostly for the income, not these people's lives. If they truly cared about the people who used these drugs, instead of throwing million dollar parties, they'd lower the drugs costs (or use the money to broaden their "Patient Access Programs" (a program that gives people who cannot afford their drugs some money to help cover costs).

I read a story not too long ago on Avastin, a patient was trying to decide if living 1-2 more months at the cost of $160,000 was really worth it since it would put his family in serious debt and his quality of life may not be great during that time.

I don't want to bash Genentech too much, they are trying to save people's lives, but they are also a business that needs to please its shareholders.

[Dick Turpin]

10:11 AM on 06/30/2011

Simply stating that Avastin "works" and leaving it at that hardly addresses the issue. Any drug must be evaluated by its "therapeutic index," which is to say, its efficacy (how well it works) relative to its safety (its side effects). Clearly, in all its approved indications, not only breast cancer, Avastin has major side effects (even compared to other cancer drugs) because it's an anti-angiogenic agent. It's no secret.

So the FDA's role is upholding a certain standard for what counts as an approvable drug. The agency does not simply approve an agent because "it works" - rather, an agent is approved because 1) it works relatively safely AND 2) that efficacy translates at least into an improved quality of life if not also an increased overall survival.

Unfortunately, patients are desperate to live - (a serious psychological problem that has nothing to do with cancer or any other disease) - and in their desperation they put faith into doctors and medicines. FDA is very right (note my value judgment here) to temper that desperation by saying to patients, in effect, "don't let your desperation cloud your better judgment." It's paternalism sure, but it's for the common good (yes, just like seat-belt laws).

Mr. Dick Turpin

[vls60]

02:14 AM on 06/30/2011

Sounds like someone didn't get his fair share of the graft monies.

[Harleygent]

11:43 PM on 06/29/2011

We get snookered by the medical and pharmaceutical industrial complex every day as PT Barnum once said. One day it is the miracle cure from the Andes the next from spider venom but none of them pan out much better than a placebo which has as high a success rate as 39% in some studies. Let face it, since Nixon declared the war on cancer in 1968 the death rates from cancers have actually increased. Yes, some things will give minor extensions of living but you still die from the disease. Also that result is with now over one Trillion dollars spend on research through private and government funding since this war started. It has let a lot of professional people get rich or executive welfare as some call it. I quit donating to any medical cures four years ago because of the negatives of above. As always, about 85%-90% of a persons demise that isn't an accident or blatant abuse is caused by our genetics. We are years, no decades away before we will see any legitimate results if any from the massive spending in these new areas of genetic. I actually believe we are now in the era that the so called genetic cures are worse than the disease and may bring about bigger problems to the human race. Enjoy life to the fullest and quit worrying. We all die, thank God!

[On My Way 58]

11:42 PM on 06/29/2011

Has anyone else noticed the assault on breast cancer lately? We are told that mamograms are not necessary until 50 (I was well under 50 with first round), we are told that meds that might give us a shot have too many side effects, etc.

Gee, seems to me the worst side effect of breast cancer would be death, but I guess that doesn't count when the disease attacks primarily women.

[Jaguar8450]

11:34 PM on 06/29/2011

The removal of this drug being an approved one by the FDA is simply this...The medical insurance health providers finally were able to bride the FDA to remove this cancer fighting drug for one reason and one reason only...And that one reason is the medical insurance provider will no longer have to paid the cost of these drugs that do help them to live longer. It's cheaper in the long run and for now for medical health insurance providers to let these women in need of this cancer fighting drug to die instead.

[emmasdolly]

11:10 PM on 06/29/2011

This sounds like the health insurance industry looking for ways to lower costs. The pharma biz, the healthcare biz and the health insurance biz are interested in ONE thing....separating you from as much of your money as possible while they torture you with "treatments" that don't cure anything and will give you NEW health problems you never had, until you die, probably from a "side effect" of a drug/treatment. The FDA is crooked as a dog's hind leg. There is no "CARE" in healthcare. It's disgusting. I don't know how these people sleep at night.

[jtsmadnow]

10:21 PM on 06/29/2011

you can bet your ass its because it does keep people alive longer and big insurance companies dont like unassing the money for meds . all the old drugs that worked great forever have been taken off the market . even meds as simple as armour thyroid . they replaced it with a horrible side affect synthetic synthroid . what pisses me off is all the tons of sodium fluoride fillers they are allowed to use in meds . my god man its pure poison . god speed to all . stay on top of these big pharmas because they are also producing your gmo foods with monsanto .

[fredicantu]

10:12 PM on 06/29/2011

There are other more dangerious drug's out in the market, some that commit murder, saying that the sideaffect causes suacide in human's, is the Food and drug addministration guilty of violation's of American Law's, drug's that have a sideaffect of suacide on the human body is not suacide, it is murder, because the pacient was not suacidal befor taking the drug that causes suacide, there for the sideaffect of the drug is inflicted in the body to cause death in any way or form, this is out right murder, the medical scientiest are getting away with murder, this medicine drug's that makes people to commit suicide murder when taken internally, in any way or form in the human body, by the law's of the United States it is a violation in crime, This people need to be brought to justice on this crime's. ANINI

[lklex]

09:55 PM on 06/29/2011

This may be an important health report, but AOL and the HuffPost seem to have forgotten (assuming, of course, that they ever knew) that June is MEN'S HEALTH MONTH. There are currently no fewer than three health reports focusing on women on AOL's "Welcome Page" and none focusing on men. The pattern continues: men and their health just don't seem to matter much at AOL and the HuffPost. Never mind, that men have a five-year shorter life expectancy and a higher age-adjusted mortality rate for both cancer and heart disease.

[lynterv]

12:08 PM on 06/30/2011

You are aware that men get breast cancer?

[ecurbwl]

09:36 PM on 06/29/2011

Purely "PROFIT MOTIVATED". Because there was not enough "profit margin" made on this drug, it will be discontinued although, this drug has been proven to be one of the best cancer fighting drugs ever made. This is an OUTRAGE ! ! !

[swoboda]

10:48 PM on 06/29/2011

It's a drug that hasn't been shown to be beneficial in advanced breast cancer. That's why it's having it's approval for that indication revoked. It's still available for proven uses. We shouldn't waste money on extremely expensive unproven options for political reasons. Reminds me of the bone marrow transplant scam for advanced breast cancer of 2 decades ago. Put a lot of women through a lot of side effects and society picked up the huge cost despite no benefit over other treatments. We still do bone marrow transplants where they have benefit. It should be the same way with this drug.

[bthechangeyouseek]

08:49 AM on 06/30/2011

When both sides are guilty of lies and spin, who is the average patient to believe?

[C Wayne Casteel]

09:26 PM on 06/29/2011

I'm sure the side effects are horrific but many testify to the fact that they are alive today because of it. If the truth was known it's probably because of Obama care and the cost of the drug. It must be expensive because I heard one woman say if she had to pay the full cost of it, it would cost her over $100,000.00 per year and she would just have to die because she couldn't afford it. The truth about Obama Care is coming to light and will do so faster as time progresses. Expensive drugs will be eliminated by the Fed and hospitals will end up being first aid centers----just as predicted from the beginning when Obama Care started.

[linkmaster]

10:44 PM on 06/29/2011

Oh heck yea! Let's get rid of Obama care! Now that I was finally able to get health coverage because of it & had my surgery done nobody needs it anymore!

[emmasdolly]

10:54 PM on 06/29/2011

The FDA has been around for years. It has nothing to do with "Obamacare". What a bunch of nitwits full of misinformation.

[ROYBOY52]

08:19 PM on 06/29/2011

Death panels don't exist? How's that Hope & Change working out for you?

[jellybaby]

08:01 PM on 06/29/2011

It is approved to treat other cancers like brian and kidney but not breast..Just wondering why..I would imagine the side effects are the same so why is it okay that certain cancer patients get it and others it is too risky for..The FDA and pharmaceutical companies never really want to see Cancer cured anyway..Too many people would be out of work...

[Jaguar8450]

11:40 PM on 06/29/2011

Who's brian and what doe he have to do with this...The only reason it is being banned is because the FDA was paid off by medical heatlh insurance providers. And that's because it's cheaper for them to let all the women in need of this medication die from this form of breast cancer than having the medical health insurance providers pay for all of it for as long as they live.

[No death panels]

11:41 PM on 06/29/2011

All cancers are different-it hasn't been proven effective enough in breast cancer, even though it has shown a survival advantage in some other cancers. It's not a conspiracy.

[ironchefjay2]

07:46 PM on 06/29/2011

To change the subject just a little I just just want to say this after reading so many of the posts on here.......If you have had or right now have cancer I just want to say "Bless you and I hope that one day soon a cure is found for you." Cancer killed my father and all I can say about it is that it is terrible.