Article showing FDA thinking of pulling Avastin OFF the market

herdizziness

News
FDA: Breast Cancer Drug Avastin Failed to Extend Lives
small text medium text large text

Print
EmailMore


By AP Jul 16th 2010 11:42AM

Categories: News
Federal health scientists say follow-up studies of a Roche breast cancer drug show it failed to slow tumor growth or extend patient lives, opening the door for a potential halt in sales.

The Food and Drug Administration approved Roche's blockbuster Avastin in 2008 based on early-stage trials showing it shrank tumors caused by breast cancer. The approval was controversial because such drugs are usually required to show increased survival time for patients.

The FDA says follow-up studies recently submitted by Roche failed to show that Avastin extended lives compared to chemotherapy alone.

On Tuesday the FDA will ask a panel of outside cancer experts to review the evidence on Avastin.

The FDA has the option to remove drug from the market.

Copyright 2010 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.

More on Breast Cancer:
Breast Cancer: Learn About It
Breast Cancer: Living With It

AnneCan

This is interesting
But I believe it has proven successful for colon cancer + a few others - I think brain is one.

Buzzard

AnneCan said:

This is interesting
But I believe it has proven successful for colon cancer + a few others - I think brain is one.

On another note...........
Its one of the reasons that my mother is able to see right now....It has lowered the blood pressure in her eye after Avastin injections to relieve the blood supply to blocked veins in the eyes causing high blood pressure behind the eye and vision loss...I heard it had just been approved for this use...I will be watching this one......

coloCan

Buzzard said:

On another note...........
Its one of the reasons that my mother is able to see right now....It has lowered the blood pressure in her eye after Avastin injections to relieve the blood supply to blocked veins in the eyes causing high blood pressure behind the eye and vision loss...I heard it had just been approved for this use...I will be watching this one......

FDA will remove it for BREAST not CRC Cancer usage
as its already proven its effectiveness here , bearing in mind that each cancer type is different, besides each tumor of the same cancer being different. .....steve

see healthday.com

PS interested in the Cancer Genome project?....check site I suggested earlier--its worth navigating

lisa42

Hi,

I saw and read this article also. It is related to the finding with breast cancer, not with colorectal cancer, so it wouldn't be taken off the market- just perhaps more limited in what cancers it can be used for. I have taken Avastin on and off over the past 3 years since diagnosis. I took it along with Folfox and with Folfiri twice, then more recently as a maintenance dose and currently together with Gemzar and Xeloda. It didn't really seem to benefit me when I took it alone as maintenance dose or even as a maintenance dose paired together with Xeloda. Recently, however, we added Avastin into the mix again after I had just been taking Gemzar and Xeloda together, my CEA did start droppping even more after the Avastin was added in. Weird- how it could seem helpful one time after it didn't do so much for me at an earlier time.

herdizziness

The sentence that got my
The sentence that got my attention was "The FDA has the option to remove drug from the market" on the fifth paragraph.

coloCan

herdizziness said:

The sentence that got my
The sentence that got my attention was "The FDA has the option to remove drug from the market" on the fifth paragraph.

I think FDA will ultimately decide to not recommend Avastin be
used for certain type(s) of breast cancer as I think its still effective in others; as for its use for CRC, thats been established .

KathiM

coloCan said:

I think FDA will ultimately decide to not recommend Avastin be
used for certain type(s) of breast cancer as I think its still effective in others; as for its use for CRC, thats been established .

I HATE the sensationalism of the press!!!
Just to sell....

SHAME on AP for propagating this stuff!!!

From another source:

http://www.msnbc.msn.com/id/38324215/ns/health-cancer/

"Panel wants Avastin withdrawn for breast cancer
Health advisers say the popular drug's risks outweigh its benefits

A panel of cancer experts said Tuesday that the government should remove its endorsement of Roche's drug Avastin for breast cancer, after follow-up studies failed to show benefits for patients.

A Food and Drug Administration panel of experts voted 12-1 in favor of removing the drug's approval for use against breast cancer alongside chemotherapy.

The FDA is not required to follow the advice of its panel, though it often does.

The negative vote is the first major setback for a blockbuster cancer drug that has racked up approvals for half a dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling only pertains to Avastin's use in breast cancer.

The FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients' lives.

As a condition of approval, Roche was required to conduct follow-up studies to demonstrate the benefits of adding Avastin to conventional chemotherapy.

But two follow-up studies recently submitted by the Swiss drugmaker did not show the same degree of delay in cancer progression as earlier studies. Additionally, patients taking Avastin did not show a significant improvement in lifespan, the gold standard of cancer treatment effectiveness.

Roche scientists argued Tuesday that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms are delayed — but panelists were not convinced.

"The study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit," said Natalie Compagni Portis, the panel's patient representative.

Panelists said they worried the drug could do more harm than good because of serious side effects, including high blood pressure, fatigue and abnormal levels of white blood cells.

"I think the burden of proof is that a drug is helpful, not that it doesn't make patients worse," said panel chair Dr. Wyndham Wilson of the National Cancer Institute. "We have definitive evidence that Avastin causes harmful side effects and we've now seen a number of well-done studies that show no advantage to lifespan."

Breast cancer is the second most-common cause of cancer death among U.S. women, according to the Centers for Disease Control. Last year more than 40,000 deaths in the U.S. were attributed to the disease."




Hugs, Kathi

herdizziness

KathiM said:

I HATE the sensationalism of the press!!!
Just to sell....

SHAME on AP for propagating this stuff!!!

From another source:

http://www.msnbc.msn.com/id/38324215/ns/health-cancer/

"Panel wants Avastin withdrawn for breast cancer
Health advisers say the popular drug's risks outweigh its benefits

A panel of cancer experts said Tuesday that the government should remove its endorsement of Roche's drug Avastin for breast cancer, after follow-up studies failed to show benefits for patients.

A Food and Drug Administration panel of experts voted 12-1 in favor of removing the drug's approval for use against breast cancer alongside chemotherapy.

The FDA is not required to follow the advice of its panel, though it often does.

The negative vote is the first major setback for a blockbuster cancer drug that has racked up approvals for half a dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling only pertains to Avastin's use in breast cancer.

The FDA in 2008 approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients' lives.

As a condition of approval, Roche was required to conduct follow-up studies to demonstrate the benefits of adding Avastin to conventional chemotherapy.

But two follow-up studies recently submitted by the Swiss drugmaker did not show the same degree of delay in cancer progression as earlier studies. Additionally, patients taking Avastin did not show a significant improvement in lifespan, the gold standard of cancer treatment effectiveness.

Roche scientists argued Tuesday that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms are delayed — but panelists were not convinced.

"The study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit," said Natalie Compagni Portis, the panel's patient representative.

Panelists said they worried the drug could do more harm than good because of serious side effects, including high blood pressure, fatigue and abnormal levels of white blood cells.

"I think the burden of proof is that a drug is helpful, not that it doesn't make patients worse," said panel chair Dr. Wyndham Wilson of the National Cancer Institute. "We have definitive evidence that Avastin causes harmful side effects and we've now seen a number of well-done studies that show no advantage to lifespan."

Breast cancer is the second most-common cause of cancer death among U.S. women, according to the Centers for Disease Control. Last year more than 40,000 deaths in the U.S. were attributed to the disease."




Hugs, Kathi

Yeppers just for Breast Cancer
The FDA is not required to follow the advice of its panel, though it often does.

The negative vote is the first major setback for a blockbuster cancer drug that has racked up approvals for a half dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling only pertains to Avastin's use in breast cancer.

See full article from DailyFinance: http://srph.it/9NYEZr