FDA set to de-list Avastin for breast cancer, just because it's too expensive

[Revere]

So much for choice! Bring on the death panels.

FDA Set To Cut Off 17,000 Women Annually From Lifesaving Drug | RedState

. Limiting access to this treatment is unthinkable and we are struggling to see any justification other than cost.

 

[Agit8r]

It looks like Roche is paid up. it should pass just fine. Unless a competing cancer treatment outbid them..

Lobbying Spending Database-Roche Holdings, 2010 | OpenSecrets

 

[xotoxi]

So much for choice! Bring on the death panels.

FDA Set To Cut Off 17,000 Women Annually From Lifesaving Drug | RedState

. Limiting access to this treatment is unthinkable and we are struggling to see any justification other than cost.

The FDA and Avastin: Breast Cancer Patients Are Thrown Another Curve In An Ongoing Saga

The FDA removed approval for Avastin for breast cancer because it was not proven to be effective. They did not take into consideration the cost.

The trials in question used standard chemotherapy with or without bevacizumab, and looked to see how long the treatment(s) delayed the progression of breast cancer (what we call "progression free survival", or PFS) as well as how long the women lived after they received their treatment ("overall survival" or OS).

The reports from a couple of years ago showed the addition of bevacizumab almost doubled progression free survival from 5.8 months to 11.3 months. However, the data at that time did not show that bevacizumab increased survival, which up to this point in time has been the "gold standard" for approving almost all cancer treatment drugs. That is one of the reasons the FDA asked for more information.

 

[uscitizen]

Studies show that Avastin can prolong the lives of patients with late-stage breast and lung cancer by several months when the drug is combined with existing therapies. Genentech expects to seek federal approval later this year to sell it specifically for those diseases. But even now, doctors, who are free to prescribe the drug as they see fit, are using Avastin for some breast and lung cancer cases — and finding its cost beyond the means of some patients.
~
With colon cancer, a year of Avastin treatment costs about $50,000. But the drug will be used at higher doses for lung and breast cancer, and Genentech does not plan to reduce the unit price, even though the additional cost of producing a higher dose is minimal. Roche executives described the pricing plans were described in a recent interview.
~
Avastin is currently used mainly in cases of late-stage colon cancer, a disease that affects about 50,000 Americans annually. On average, those patients take the drug for 11 months and it extends their lives an average of 5 months, compared with other treatments.

http://www.nytimes.com/2006/02/15/business/15drug.html?pagewanted=all

Sounds like Genetech plans to rip off people dying from breast cancer to me.

 

[uscitizen]

bump for more input on this.

 

[uscitizen]

bump

 

[waltky]

Mebbe dey tryin' to bring it back...

Studies: Avastin may fight early breast cancers
Wed Jan 25,`12: Surprising results from two new studies may reopen debate about the value of Avastin for breast cancer. The drug helped make tumors disappear in certain women with early-stage disease, researchers found.

Avastin recently lost approval for treating advanced breast cancer, but the new studies suggest it might help women whose disease has not spread so widely. These were the first big tests of the drug for early breast cancer, and doctors were cautiously excited that it showed potential to help. In one study, just over one third of women given Avastin plus chemotherapy for a few months before surgery had no sign of cancer in their breasts when doctors went to operate, versus 28 percent of women given chemo alone. In the other study, more than 18 percent on Avastin plus chemo had no cancer in their breasts or lymph nodes at surgery versus 15 percent of those on chemo alone.

A big caveat, though: The true test is whether Avastin improves survival, and it's too soon to know that — both studies are still tracking the women's health. The drug also has serious side effects. "I don't think it's clear yet whether this is going to be a winner," Dr. Harry Bear of Virginia Commonwealth University said of Avastin. But he added, "I don't think we're done with it." Bear led one study, in the United States. Dr. Gunter von Minckwitz of the University of Frankfurt led the other in Germany. Results are in Thursday's New England Journal of Medicine.

Avastin (uh-VAS'-tihn) is still on the market for some colon, lung, kidney and brain tumors. In 2008, it won conditional U.S. approval for advanced breast cancer because it seemed to slow the disease. Further research showed it didn't meaningfully extend life and could cause heart problems, bleeding and other problems. The government revoked its approval for breast cancer in November. Now doctors can prescribe Avastin for breast cancer but insurers may not pay. Treatment can cost $10,000 a month. The drug is made by California-based Genentech, part of the Swiss company Roche. It is still approved for treating advanced breast cancer in Europe and Japan.

The new studies tested it in a relatively novel way — before surgery. This is sometimes done to shrink tumors that seem inoperable, or to enable women to have just a lump removed instead of the whole breast. The women in the studies had tumors that were large enough to warrant treatment besides surgery. Their cancers were not the type that can be treated by Herceptin, another widely used drug. In the U.S. study, 1,200 women were given chemo or chemo plus infusions of Avastin. By the time of their surgery, no cancer could be found in the breasts of more than 34 percent of those given Avastin versus 28 percent of the others. (Surgeons still have to operate because they don't know the tumor is gone until they check tissue samples.)

MORE

 

[waltky]

Avastin not much help with brain tumors either...

Avastin fails studies in new brain tumor patients
2 June`13 — New research raises fresh questions about which cancer patients benefit from Avastin, a drug that lost its approval for treating breast cancer nearly two years ago.

Avastin did not prolong life when used as a first treatment for people with brain tumors like the one U.S. Sen. Edward Kennedy died of several years ago, two studies found. In one, patients who were expected to benefit the most from Avastin based on genetic testing had the worst survival rates. Side effects also were more common with Avastin. The drug is approved for treating brain tumors that have recurred for people who already tried chemotherapy or radiation. But that approval was based on studies suggesting it briefly delayed the worsening of the disease. No definitive study shows it helps those patients live longer, either. Something similar happened with breast cancer: Avastin won the Food and Drug Administration's approval after studies suggested it delayed disease progression. But when later research showed it did not prolong life and brought more side effects, its approval for breast cancer was revoked.

However, many cancer experts say the same thing should not happen now, and that Avastin should retain its approval for brain cancer patients whose disease has recurred. "I would definitely not want the FDA to take that away from patients," said Dr. Deepa Subramaniam, director of the brain tumor center at Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C. "That's very different from the breast cancer story," where there are many other drugs that can be tried, she said. She had no role in the new studies, which were discussed Sunday at an American Society of Clinical Oncology conference in Chicago.

Avastin, made by Swiss-based Roche's Genentech unit, acts by depriving tumors of a blood supply. It's also sold for treating certain colon, lung and kidney tumors. Another study discussed Sunday and released previously showed it helped women with advanced cervical cancer live nearly four months longer. The new brain cancer studies tested it as initial treatment for glioblastoma, the most common and deadly type of tumor. About 10,000 Americans each year are diagnosed with these tumors, which are nearly always incurable.

In one study, 637 patients received standard chemotherapy plus radiation, and half also received Avastin. Both groups lived about 16 months, and those on Avastin had more side effects — mostly low blood counts, blood clots and high blood pressure. "Our study would strongly suggest that it is not beneficial to do it as front-line treatment but to reserve it as second-line or salvage therapy," said study leader Dr. Mark Gilbert of the University of Texas MD Anderson Cancer Center in Houston. Federal grants and Genentech paid for the study, and Gilbert consults for the company.

More Avastin fails studies in new brain tumor patients

 

[Katzndogz]

Avastin worked for years. As soon as the government didn't want to pay for it , the government got brand new government backed studies saying it doesn't work. This follows all the other government funded studies proving mammograms, pap tests and prostate screenings don't work. They worked right up to obamacare. Now they stopped working. The government paid for studies to prove it.