Last Updated: 2011-06-30 16:40:17 -0400 (Reuters Health)
By Katie Reid
ZURICH (Reuters) - Swiss drugmaker Roche Holding AG had nothing to lose by giving Avastin another roll of the dice, and by doing so showed the world it still believes the drug should be used in breast cancer.
The world's largest maker of cancer drugs is now poised to carry out another trial in a bid to prove the $6-billion drug does significantly extend the time women live without their disease getting worse.
Importantly, this trial will also include a biomarker to see if certain patients might benefit more from Avastin. Roche has recently pushed ahead with targeted therapies and has had recent success with its experimental skin cancer drug vemurafenib.
U.S. health advisers' unanimous rejection of Avastin to treat breast cancer endorses a Food and Drug Administration move in December to revoke its approval in breast cancer, and is likely to deal Roche a hefty blow.
The group stands to lose around $1 billion in sales if FDA Commissioner Margaret Hamburg finally follows the advice of the panel.
But the emotional pleas from women at the FDA hearing on Tuesday and Wednesday who are fighting the illness show that Roche and its U.S. unit Genentech are not alone in supporting the drug in this setting.
Indeed, European authorities have just given the green light for use of Avastin with a second type of chemotherapy, broadening its use on this side of the Atlantic, and the drug can be used for breast cancer in more than 80 countries.
"Roche/Genentech have shown to the public world that they continue to stand fully behind one of their most important drugs, with a suggestion that a potential withdrawal of the indication merely reflects bad decision making by a regulatory agency," Bernstein analyst Tim Anderson said in a note.
"This will keep at least some patients, prescribers, and payers on board because even with an officially-withdrawn indication Avastin can still be used 'off label'. What changes most is who will then pay for the drug," he said.
U.S breast cancer patients may have to cover the costs of Avastin themselves as the drug may not be covered by health insurance companies if it is not endorsed by the FDA.
But Medicare will continue to pay for the drug for breast cancer, regardless of FDA's final decision, a spokesman for said Thursday.
The estimated cost for Avastin for metastatic breast cancer is $88,000. This is based on people taking Avastin for approximately 11.3 months, Roche said.
Genentech unit has limited the annual cost of Avastin to $58,000 for patients taking Avastin for any FDA approved indication.
"In the event FDA decides to withdraw Avastin, they may put in place a transition programme for metastatic breast cancer patients currently using Avastin," analysts at Nomura said in a note.
"In the case of AstraZeneca's Iressa, FDA allowed such patients to complete their treatment while not recommending use in new patients," the analysts said.
A FALLEN STAR
A couple of years ago, Avastin was widely expected to be the world's biggest selling drug by the middle of the decade. That title is now expected to go to Abbott Laboratories' rheumatoid arthritis drug Humira, according to consensus sales figures compiled by Thomson Reuters Pharma.
The Roche drug has been beset by a number of disappointments over the last 18-months, failing in prostate and stomach cancer.
Roche is now banking on Avastin use in ovarian cancer to drive future sales growth.
Avastin won U.S. clearance for breast cancer in 2008 based on a study showing the drug stalled breast cancer growth by 5.5 months more when used in combination with standard chemotherapy. As part of an accelerated approval, the FDA required Roche to run follow-up studies.
Later studies found only a one- to three-month delay in breast cancer growth. None of the studies showed Avastin extended the lives of patients with advanced breast cancer.
Some patients also had severe side effects, including holes in the stomach and intestines, severe bleeding and blood clots.
The company says the incidence of these serious side effects was just under 3 percent greater for those taking Avastin.
In December, the FDA proposed revoking Avastin's clearance for breast cancer, while keeping the drug on the market for colon, lung, brain and kidney cancers.
"For Roche, the drama was 12 months ago. They have now adapted. What will be interesting will be to see what others do as oncology is the largest area of research. Others may get a bloody nose as the FDA flip flops around," Vontobel analyst Andrew Weiss said.
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