WASHINGTON: An expert panel on Wednesday urged the US Food and Drug Administration 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 haemorrhage and does not prolong overall survival in women suffering from breast cancer, the panel said.
The panel's recommendation did not affect the use of Avastin to treat other cancers, including colon and lung cancers.
Avastin had been approved three years ago for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.
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.
"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.
However, the FDA panel decided that Genentech's arguments were not enough to sway it 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 Centre for Biologics Evaluation and Research who presided at 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 has 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.
European medical experts have urged that the drug be restricted to use in combination with paclitaxel only instead of other forms of chemotherapy because benefits were uncertain.
