US panel rejects Avastin for breast cancer use

Jun 29, 2011

An expert panel urged the US Food and Drug Administration on Wednesday to strip the Roche-made drug Avastin of its label for use against breast cancer because it is neither safe nor effective.

After a rare two-day appeal hearing by Genentech, a US unit of the Swiss pharmaceutical giant, the panel voted 6-0 to uphold its earlier recommendation in December to stop the use of Avastin for breast cancer.

The drug, also known as bevacizumab, carries risks such as severe high blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer, the panel said.

A final decision by the FDA commissioner must be issued, but will not likely come before the end of July. The FDA does not have to follow the recommendations of the expert panel but it usually does.

The docket will remain open until July 28 for public comment, and a final decision will follow, though an exact date has not been announced.

"The commissioner's decision related to breast cancer will not affect Avastin's approved indications for use in colon, lung, kidney, and brain cancers," the FDA said.

"That is, regardless of the final decision on metastatic breast cancer approval, Avastin will remain on the market."

Some members of the public, including women dressed in pink who carried signs that read: "I am more than a statistic" had clustered outside the FDA building where the hearing took place, according to media reports.

Breast cancer patients who were taking Avastin were allowed to talk about their experiences.

Afterward, Terry Kalley, founder of Freedom of Access to Medicines (FAMEDS), said he was disappointed, but not surprised, with the decision.

"This panel that has passed judgment on a life or death matter with breast cancer should have been made up of breast cancer specialists and oncologists, but it had zero breast cancer specialists or oncologists on it," Kalley said in a press release Wednesday after the decision.

"We had breast cancer oncologists testifying on our behalf yesterday to keep patient access to Avastin."

Kalley's wife has late stage breast cancer and has been "immensely helped by Avastin," according to the statement.

However, the FDA panel decided that arguments in favor of the drug were not enough to sway the panel from its earlier decision.

Initial trial results that showed patients had an extra five months of "progression-free survival" could not be replicated, and some deaths were associated with the drug, the FDA said.

"The hearing has also provided an opportunity for the public to observe and participate in the type of difficult decision-making process that the FDA engages in each day as it considers the approval or the withdrawal of approval, of drug products," said Karen Midthun, director of the Center for Biologics Evaluation and Research who presided over the hearing.

"As illustrated by the public presentations at the beginning of the hearing, FDA's focus is always on the effect that our decisions will have on patients who will use those products, including those patients who may be benefited by them, and those who may also be harmed by them."

Genentech said the drug would remain approved for use in combination with the chemotherapy drug paclitaxel for first-line treatment of metastatic HER2-negative breast cancer until the FDA makes a final decision.

"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options," said Hal Barron, Genentech's chief medical officer and head of global product development.

Avastin is designed to prevent new blood vessels from reaching tumors and providing them with the nutrients they feed on to grow. During the first clinical trial, when combined with Taxotere, the drug had stifled cancer progression and increased patient survival.

"We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin," Barron added.

Roche could lose $1 billion in annual revenue if Avastin is taken off the market for breast cancer treatment, according to figures cited in the media.

European medical experts have called for the drug to be restricted to use in combination with paclitaxel only instead of other forms of chemotherapy because benefits were uncertain.

Explore further: Evidence lacking for long-term opioid use in low back pain

add to favorites email to friend print save as pdf

Related Stories

FDA panel: Revoke drug's breast cancer approval

Jun 28, 2011

(AP) -- A panel of cancer experts has ruled for a second time that Avastin, the best-selling cancer drug in the world, should no longer be used in breast cancer patients, clearing the way for the government to remove its ...

FDA says breast cancer drug did not extend lives

Jul 16, 2010

(AP) -- Federal health scientists said Friday that 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 withdrawal in that indication.

Experts veto Avastin as a breast cancer treatment

Jul 20, 2010

(AP) -- 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.

Hearing may be end of road for breast cancer drug

Jun 27, 2011

(AP) -- The best-selling cancer drug in the world comes under federal scrutiny once again this week, as drugmaker Roche makes a last-ditch effort to keep Avastin approved for breast cancer, despite evidence ...

Recommended for you

Drug watchdog urges vigilance in cancer drug theft

50 minutes ago

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

Pyridoxine-doxylamine drug safety data lacking

Apr 16, 2014

(Medical Xpress)—The most commonly prescribed drug for pregnant women suffering from morning sickness in their first trimester does not prevent birth defects even though drug safety data says it does, according to research ...

User comments : 0

More news stories

Turning off depression in the brain

Scientists have traced vulnerability to depression-like behaviors in mice to out-of-balance electrical activity inside neurons of the brain's reward circuit and experimentally reversed it – but there's ...

Proper stem cell function requires hydrogen sulfide

Stem cells in bone marrow need to produce hydrogen sulfide in order to properly multiply and form bone tissue, according to a new study from the Center for Craniofacial Molecular Biology at the Herman Ostrow School of Dentistry ...

There's something ancient in the icebox

Glaciers are commonly thought to work like a belt sander. As they move over the land they scrape off everything—vegetation, soil, and even the top layer of bedrock. So scientists were greatly surprised ...

Clean air: Fewer sources for self-cleaning

Up to now, HONO, also known as nitrous acid, was considered one of the most important sources of hydroxyl radicals (OH), which are regarded as the detergent of the atmosphere, allowing the air to clean itself. ...