Last Updated: 2011-06-29 17:00:31 -0400 (Reuters Health)
By Anna Yukhananov
SILVER SPRING, Md. (Reuters) - U.S. health advisers delivered a blow to Roche Holding on Wednesday, voting to reject the use of Roche Holding drug Avastin for breast cancer while the Swiss drugmaker conducts more studies.
Roche stands to lose nearly $1 billion in Avastin revenue as the U.S. Food and Drug Administration advisers upheld the agency's December decision to revoke the medicine's use in breast cancer.
Wrapping up a rare two-day appeal hearing, the panel also reiterated its view that Avastin is not clinically beneficial, effective or safe for treating breast cancer - to a fiery response from patients, who earlier shared tearful testimonies that the drug saved their lives.
"No matter what way we look at it, there's nothing we can hang our hat on in these studies that would make me feel comfortable continuing to expose a lot of patients to risk without a clear benefit," said Mikkael Sekeres, associate professor of medicine at the Cleveland Clinic Taussig Cancer Institute and one of the panel members.
Roche argued that Avastin, which generated $6 billion in sales to treat several types of cancers, should remain available to breast cancer patients while the company conducts more studies on its clinical benefits.
Without FDA approval, insurance companies and government health programs likely will stop covering the $8,000-a-month drug, potentially jeopardizing treatment for an estimated 17,000 women using the medicine.
FDA officials said the side effects and unclear effectiveness of the drugs presented in the latest data makes approval of Avastin for breast cancer inappropriate, especially since follow-up studies of the drug would take at least three-and-a-half years - and even longer for final results.
The company said the drug works best with a specific type of chemotherapy called paclitaxel, and follow-up studies would look at that combination, as well as which patients best respond to treatment.
The company also has said Avastin may work better for certain kinds of patients based on their genetic markers, and future studies would look at how best to identify them.
"This path forward is clearly allowed by law and supported by science," Dr. Hal Barron, chief medical officer at Roche's unit Genentech, said on Wednesday. "And it's clearly in the best interests of patients."
"So we're looking at about 2016 or 2017, when we could potentially be right back here to determine critical benefit in regard to withdrawal?" Carla Cartwright, attorney for the FDA, asked Genentech during a cross-examination.
Industry analysts had predicted the FDA panel's vote, especially as five of its six panel members voted against Avastin's use in breast cancer at a hearing last July. FDA Commissioner Margaret Hamburg will make a final decision based on Wednesday's vote at a later time.
Breast cancer is the second-most common type of cancer among women after skin cancer. One in eight U.S. women are expected to develop invasive breast cancer during their lives.
Avastin won U.S. clearance for breast cancer in 2008 based on a study showing the drug stalled 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 to confirm the drug worked.
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.
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