Entries in Avastin (12)


Cancer Patients Fume Over Counterfeit Avastin

J.B. Reed/Bloomberg News(OCEANSIDE, Calif.) -- Cancer patients are furious that a counterfeit version of the drug Avastin has landed in U.S. clinics.

Avastin, which is made by the Oceanside, Calif.-based company Genentech, is used in combination with chemotherapy to treat cancers of the colon, brain, kidneys and lungs. But the counterfeit lacks the tumor-starving ingredient some patients need to survive.

"It's an outrage," said Diane Barraza, 48, who takes Avastin for stage IV colon cancer. "For a company to sell this drug, put it in our blood, it's an outrage."

The U.S. Food and Drug Administration announced Tuesday that 19 clinics in California, Texas and Illinois may have purchased the phony Avastin from Quality Specialty Products, an "unapproved" foreign supplier also known as Montana Health Care Solutions. The counterfeit vials are labeled "Avastin" but indicate "Roche" as the manufacturer. Roche is the parent company of Genentech.

"The counterfeit contains no Avastin, no generic Avastin, no active ingredient whatsoever," Genentech spokesman Ed Lang told ABC News. Lang said the contents of the vials are still under investigation.

For patients like Barraza, a fake cancer drug would be the cruelest con.

"To sit in the chemo chair and watch that stuff drop into my veins," said an emotional Barraza, who lives in Fullerton, Calif., with her 6-year-old daughter. "It's all I've got. And it might just be water?"

Avastin is expensive, costing upwards of $650 for a small vial. But Montana Health Care Solutions sold the counterfeit vial for $480, according to one of the clinics -- a cost savings of 25 percent.

"Obviously it makes good business sense to try to get the drug at a reduced cost," said Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley, Calif. "But when you start to get drug pricing that's markedly different from that of the standard distributor, it should raise a red flag."

Only four U.S. distributors are authorized to sell Avastin to doctor's offices; another four can sell the drug wholesale to hospitals. Montana Health Care Solutions is not an authorized Avastin distributor. Jacoub, who treats Barraza, said his clinic buys Avastin in bulk from an approved distributor for $593.20.

Montana Health Care Solutions claimed to be based in Belgrade, Mont. But the company's recently disconnected phone number has a New Brunswick, Canada, area code. It's unknown whether Montana Health Care Solutions knew the Avastin was counterfeit. They also sold other cancer drugs, including Neulasta and Faslodex, at a significantly discounted price.

The FDA was alerted to the possible counterfeit in December 2011 by the Medicines and Healthcare Products Regulatory Agency in the UK, according to Genentech's Lang. In a Feb. 10 letter, the agency urged the 19 clinics known to have purchased through unapproved distributors to "retain and secure" any unused drugs. The counterfeit Avastin vials have the lot numbers B86017, B6011, B6010, and the labels are slightly different.

Counterfeit or illegally imported drugs are rare in the U.S. but not unheard of. In 2008, heparin (a blood thinner) imported from China killed 81 Americans.

"Counterfeit drug makers have reached a level of sophistication where the real and fake products look almost identical," said Peter Pitts, president of the Center for Medicine in the Public Interest and former associate commissioner for the FDA. Pitts estimated that counterfeit drugs generated $75 billion in 2010, a figure expected to grow by 20 percent annually. "It's a low-risk, high-reward proposition. It's almost a perfect crime -- people aren't getting the drugs they need and they end up dying."

For Barraza, who will have four more Avastin treatments over the next two months, the thought of criminals profiting from her disease is sickening.

"I wish they could understand what it feels like to be a cancer patient, to take a drug and to suffer," she said. "I'd do anything to stay alive, but I need the right medication."

Copyright 2012 ABC News Radio


Can Giving Drugs to Breast Cancer Patients Before Surgery Save Lives?

Comstock/Jupiterimages(NEW YORK) -- Breast cancer is difficult to treat and, once treated, the potential for recurrence looms large.  So instead of just treating breast cancer after it returns, there is also great research interest in giving drugs prior to surgery.  The hope is that if they can shrink the tumor before the surgery, it will reduce the chance of recurrence and hopefully extend patients lives.

In research released Wednesday in the New England Journal, two studies suggest that Avastin, a drug recently taken off the market for use in metastatic breast cancer, might have potential to shrink breast tumors before surgery.

The studies were conducted in Europe and North America.  The European study enrolled 1,948 patients.  The results were particularly interesting for a group of patients suffering from a form of “triple negative” breast cancer, which is less common but more aggressive.  Dr. Gary Lyman of Duke University, who was a member of the Food and Drug Administration panel that voted to remove Avastin’s approval for metastatic breast cancer, says that this group of patients represents 15,000 to 20,000 of all 200,000 newly diagnosed cases of breast cancer.

According to the study, patients with this type of breast cancer that received Avastin along with standard therapy had greater rates -- about 11 percent -- of complete tumor disappearance.  However, researchers noted that Avastin resulted in a greater rate of toxic effects such as high blood pressure, skin reactions and infections.

The North American study enrolled 1,206 patients and also showed that patients receiving Avastin significantly increased the rate of complete tumor disappearance, by 6 percent.

Dr. Stefan Gluck of the University of Miami says, “We oncologists need to assess and chose very wisely. Triple negative cancers are usually very aggressive and not sensitive to chemotherapy, so the addition of Avastin can help at least temporarily.”

Dr. Lyman agrees and says, “Women in earlier stage of disease should be considered candidates, although we haven’t learned which specific patients will benefit the most.  The results of these studies do not improve overall survival but can be given to patients prior to surgery to reduce tumor burden and improve surgical outcomes.”

Most experts concur with this sentiment and recommend that further studies showing improvement in survival are necessary.

Copyright 2012 ABC News Radio


Breast Cancer: FDA Revokes Avastin Approval

J.B. Reed/Bloomberg News(WASHINGTON) -- The U.S. Food and Drug Administration announced Friday it will revoke the approval of Avastin for breast cancer, citing a lack of evidence that the benefits outweigh the risks.

Avastin was approved for metastatic breast cancer in February 2008 under the agency's accelerated approval program, which offers patients early access to promising drugs while confirmatory clinical trials are carried out.

"Unfortunately the additional studies failed to confirm Avastin's initial promise," FDA Commissioner Dr. Margaret Hamburg said Friday.

The additional studies, carried out by Avastin's maker Genentech, found only a small effect on tumor growth and no evidence that patients lived longer than they would taking standard chemotherapy. Because the drug can cause severe high blood pressure, bleeding, heart failure, and perforations in the nose, stomach and intestines, an FDA advisory panel in June recommended revoking its approval.

The recommendation triggered an outcry from breast cancer patients who say Avastin slowed their disease. But without a reliable indicator of which women with breast cancer might benefit, Hamburg said she was unable to leave it on the market for that use.

"I feel deeply for these women who are seeking therapies that may work for them," she said, adding that she was speaking as a doctor and a woman. "Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing."

The drug will remain on the market for treatment of other cancers, which means breast cancer patients can use it off-label.

Copyright 2011 ABC News Radio


FDA: Cancer Drug Avastin, May Cause Ovarian Failure

iStock/Thinkstock(WASHINGTON) – According to the U.S. Food and Drug Administration (FDA), treatment with Roche Holding AG’s cancer drug Avastin might have a detrimental effect on fertility in some women.

A new warning detailing the risk of “ovarian failure” was recently added to Avastin’s label, and doctors are now recommended to warn women of child-bearing age of the risk before they start treatment.

Ovarian failure means that there is a possibility that ovaries will stop releasing eggs regularly.

Avastin is most commonly used to treat certain types of lung, brain, kidney, colon and breast cancers, and though it is currently approved to treat each of the aforementioned cancers, the company is currently fighting to keep the FDA’s approval for breast cancer.

The pending decision from the FDA commissioner on whether to take away its approval for breast cancer is separate from the recent announcement about the drug's label revision -- part of routine practice. The FDA often revises drug labels when new data or side affects arise.

In a statement, Roche's Genentech unit said it "takes patient safety very seriously and consistently reports new safety information about our medicines, collected through clinical trials and in the postmarketing setting" to the FDA. The company also added that it is planning to send healthcare professionals a letter that would discuss any new labeling changes.

The updated information regarding ovarian failure came from a clinical trial of a study of 179 women with colon cancer. In addition to being treated with chemotherapy regimen, Folfox, half the women also received Avastin. Of those who received Avastin, 34% experienced ovarian failure compared to 2% of those not taking Avastin.

Ovarian function was restored to about 20% of the women after the Avastin treatment was stopped.

The FDA report also added that "Long-term effects of Avastin exposure on fertility are unknown.”

Copyright 2011 ABC News Radio


Five More Patients Blinded by Avastin

J.B. Reed/Bloomberg News(LOS ANGELES) -- Five Los Angeles patients receiving Avastin to treat eye disease have been blinded, The New York Times reported.

The report came after an alert issued by the U.S. Food and Drug Administration Tuesday that 12 patients in the Miami area had suffered eye infections, some leading to blindness, after Avastin injections.

Avastin, made by Genentech, blocks the growth of new blood vessels. Developed and FDA-approved as a cancer drug, Avastin has increasingly been used, outside its approved indication, as a cheap treatment for wet macular degeneration -- an eye disease caused by abnormal blood vessel growth. The drug is injected directly into the eye.

The approved treatment for macular degeneration, another Genentech drug called Lucentis, costs about $2,000 per injection compared to Avastin’s $50 price tag. The drugs have the same mode of action. But because Avastin is sold in doses designed for intravenous chemotherapy, doctors are forced to divide it into smaller eye-appropriate doses -- a practice that opens the door for bacterial contamination.

“Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections,” the FDA warned Tuesday. "Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered."

The 12 Florida eye infection cases were traced back to a single pharmacy in Hollywood, Fla., the FDA reported. The pharmacy repackaged each 4 millimeter vial of Avastin into four 1 millimeter single dose syringes distributed throughout the region.

A contamination source has yet to been identified in the Los Angeles cases, according to the Times.

Copyright 2011 ABC News Radio


Should Medicare Move to Cheaper Drugs?

Creatas Images/Thinkstock(WASHINGTON) -- If there are two drugs that achieve the same result but one costs $2,000 per dose and the other costs $50, should Medicare opt to cover the cheaper one and not the more expensive one?

That’s the question senators on the Special Committee on Aging aimed to answer Thursday at a hearing on reducing prescription drug costs -- costs that are expected to double between 2008 and 2019.

The drugs in question are Lucentis and Avastin. Both are produced by the same company, Genentech, and both prevent blindness caused by wet age‐related macular degeneration, the leading cause of blindness in people over 50.

Lucentis, the more expensive option, is FDA-approved and has few known side effects. Along with one other drug, Lucentis accounts for 16 percent of the $12.5 billion Medicare Plan D spent on prescription drugs last year.

Avastin, the less-costly option, is a newer drug that has not yet been approved by the FDA. Some studies show that the drug may increase the risk of stroke and death, but no conclusive evidence has yet been produced.

Medicare covers both drugs, and despite more doctors prescribing Avastin, the “vast majority of the spending is for Lucentis,” said Jonathan Blum, the director of the Center for Medicare.

As of 2008, about 60 percent of physicians had started prescribing the “off-label” drug instead of Lucentis to save money for their patients, said Phillip Rosenfeld, a professor of ophthalmology at the University of Miami Miller School of Medicine. The move toward Avastin saved Medicare $800 million in 2008 alone, he said.

At a time when lawmakers are looking to slash budgets and decrease deficits, cost-saving measures like choosing low-cost drugs over similar but significantly more expensive ones may be part of the answer to closing huge budget shortfalls in programs like Medicare and Medicaid.

Tunis argued that the price Medicare pays for a drug should be linked with the drug’s effectiveness in relation to other drug options. In the case of Lucentis and Avastin, that would mean Medicare would pay a similar price for both drugs.

But under current law, Medicare is powerless to negotiate a price structure like that. The Medicare Modernization Act of 2003 requires Medicare to pay six percent more than the average sale price for prescription drugs, no matter the alternatives.

The downside of opting for low-cost alternatives to high-priced, brand-name drugs is that it would decrease funding for research and development, Tunis said. The Lucentis development program, for example, was one of the most expensive in Genentech’s history, said Anthony Adamis, the global head of ophthalmology at Genentech.

Lucentis’ clinical trials alone cost $1.1 billion, spanned 11 years and involved 7,100 patients.

Adamis said that because the vast majority of the drugs that go through clinical trials fail, the few that make it to market have to pick up the tab for all the failures.

Tunis argued that with research and development grants, innovation would not suffer, but the overall cost of prescription drugs could be reduced.

“It would be a very important way for Medicare to spend less on drugs and not harm beneficiaries at all,” he said.

Copyright 2011 ABC News Radio


Medicare to Continue to Cover Avastin Regardless of What FDA Decides

Comstock/Thinkstock(WASHINGTON) -- Medicare will continue to cover Avastin for breast cancer treatment even if U.S. Food and Drug Administration Commissioner Peggy Hamburg decides to withdraw Avastin for such use, according to Don McLeod, a spokesman for the Centers for Medicare and Medicaid.

An FDA advisory committee recommended unanimously that Avastin no longer be used to treat breast cancer, saying that the risks of the drug far outweighed any benefits.

Avastin is currently used to treat other types of cancer in the U.S., including advanced colorectal, lung, kidney and brain cancers. The recommendation made by the advisory panel only affected its use for advanced stage breast cancer.

The drug will remain "on label" for breast cancer until Hamburg makes a final decision. Regardless, McLeod said, CMS will continue to cover Avastin for breast cancer.

The FDA's recommendation came at the end of a two-day hearing that pitted the agency's Center for Drug Evaluation and Research against Genentech, Avastin's manufacturer.

Following the vote, some, presumed to be breast cancer patients and their families, interrupted the hearing as they expressed their disappointment at the panel's decision.

Although a handful of patients testified Tuesday that Avastin helped in treating their metastatic breast cancer, a review of studies conducted by the FDA's Center for Drug Evaluation and Research convinced the panel that Avastin should no longer continue to be marketed as a treatment for advanced breast cancer.

Copyright 2011 ABC News Radio


FDA Panel: Avastin Ineffective for Treating Advanced Breast Cancer

Comstock/Jupiterimages(WASHINGTON) -- The pleas of cancer patients and the arguments of drugmaker Genentech failed to convince a panel of Food and Drug Administration advisors that the agency should let Avastin continue to be marketed as a treatment for advanced breast cancer.

The six-member cancer drug advisory committee, a panel of outside experts, agreed unanimously that there is no evidence Avastin works and ample evidence that it is unsafe. They also voted unanimously to urge the FDA to reject Genentech's call for a "middle ground" approach that would allow the drug to stay on the market for a limited subset of women until more studies can be completed.

The decision on whether to stay the course and withdraw the approval of this drug for breast cancer now rests with the commissioner of the FDA.

Copyright 2011 ABC News Radio


Avastin Pits Breast Cancer Patients Against FDA Experts

Comstock/Thinkstock(WASHINGTON) -- Priscilla Howard, who has metastatic breast cancer, has been taking the drug Avastin for a little more than two years and has seen a remarkable difference in the progression of her disease, she told a panel of experts at the U.S. Food and Drug Administration during the first day of a two-day hearing that pits the FDA's Center for Drug Evaluation and Research against Genentech, Avastin's manufacturer.

"I am progression-free but not cancer-free," said Howard, one of a handful of Avastin patients who gathered both inside and outside the FDA to fight for keeping Avastin on the market.

"I want every available weapon in my arsenal as I fight this devastating disease," Howard told the panel. The hearing will ultimately decide the fate of what some patients consider a life-saving drug.

Although a handful of breast cancer patients testified Tuesday that Avastin helped in treating their metastatic breast cancer, a review of studies conducted by the FDA's Center for Drug Evaluation and Research suggests the risks outweigh the benefits of Avastin for treating breast cancer, FDA officials said at the hearing.

The FDA granted an accelerated conditional approval for Avastin in February 2008 to treat late-stage breast cancer patients. It had been suggested that the drug slowed the progression of the disease and improved overall survival.

But results from four trials that enrolled more than 3,000 women found no significant reduction in progression of the disease or improvement of death rates among those who took Avastin and underwent chemotherapy.

"The decision must be based on the totality of evidence in all clinical trials," Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, said at the hearing Tuesday. "The totality of data submitted to FDA shows it's not safe and effective [for treating] breast cancer."

The hearing is the culmination of recommendations to begin regulatory withdrawal of the drug for use on breast cancer patients. Some cancer specialists said the decision could hold huge implications for the way their patients will be treated.

"This decision [could] remove an option for patients," said Dr. Edith Perez, clinical oncologist at the Mayo Clinic.

Doctors had previously reported seeing their patients benefit by taking Avastin, but it's not clear which patients it helps the most.

"We will be working hard to make sure that patients who are getting Avastin and seeing good control of their cancer will continue to get Avastin with their treatment," Dr. Gretchen Kimmick, medical oncologist at Duke University Medical Center, told ABC News in December.

Still, the FDA studies found no overall benefit from the drug, and even suggested that some patients increased their risk of death because Avastin is, in some ways, toxic.

Copyright 2011 ABC News Radio


Study Finds Cancer Drug Avastin May Be Cheap Alternative for Eye Disease

Banastock/Thinkstock(PHILADELPHIA) -- Results from a study comparing Avastin (a cancer treatment drug) and Ludentis (a drug used to treat a degenerative eye disease) confirmed that the two are nearly equal in effectiveness for improving visual acuity lost as a result of age-related macular degeneration (AMD), according to MedPage Today.

According to the study, published online Thursday in the New England Journal of Medicine, patients who received monthly doses of Avastin gained 8.0 letters of visual acuity compared to an 8.5 letter improvement that Ludentis produced.

Members of the opthalmology community had much looked forward to the release of the study's findings, given the substantial price difference of the two drugs, both made by Genentech.  One dose of Avastin, approved by the FDA only for cancer treatment costs, about $50, while one dose of Ludentis, approved only for AMD, will run patients about $2,000. 

Fearing the impact such a study could have on the sales of the more expensive Ludentis, Genetech has been reluctant, MedPage reports, to fund a head-to-head trial between the two.  As a result, the National Eye Institute provided funding for the study, called the Comparison of AMD Treatment Trials (CATT).

Copyright 2011 ABC News Radio 

ABC News Radio