4 Min Read
* FDA advisers due to vote on Avastin appeal
* Roche says FDA has flexibility to keep breast cancer use
* FDA says agency must follow the data
* Roche shares up 1.4 percent with wider market rally
By Anna Yukhananov
SILVER SPRING, Md., June 29 (Reuters) - Swiss drugmaker Roche Holding argued for more time to study the effect of its Avastin medicine for breast cancer as U.S. health advisers prepared to vote on the fate of the treatment.
The U.S. Food and Drug Administration was due to wrap up a rare two-day hearing on Avastin later on Wednesday after hearing tearful testimony from patients who said the drug saved their lives.
Roche ROG.VX stands to lose nearly $1 billion in Avastin revenue if FDA advisers uphold the agency's decision to revoke its use in breast cancer. The FDA based its December decision on data that shows the treatment did not help patients live longer, and only delayed cancer growth by one to three months.
Roche said Avastin, which generated $6 billion in sales to treat several types of cancers, should remain available to breast cancer patients while the company conducts further studies on its clinical benefits.
"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."
FDA officials said the agency had to proceed on the basis of the latest data, and that it would be inappropriate to keep the breast cancer approval since follow-up studies would take at least three years.
Industry analysts do not expect the FDA to change its stance, 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 after the panel's recommendation on Wednesday.
Roche shares rose 1.4 percent in European trading on Wednesday, in line with a 1.1 percent rise in the European healthcare index .SXDP.
Doctors still could use Avastin for breast cancer if the FDA rejects Roche's appeal. But 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.
Breast cancer patients testified on Tuesday that Avastin saved their lives, and some said Genentech should offer free Avastin for those patients that respond well to the drug while it studies which patient populations could benefit.
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. [ID:nN1E75P03C]
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.
Genentech has argued that the extension of time without cancer growing was meaningful for patients with advanced breast cancer. At that stage, the disease cannot be cured and the goal is to stabilize patients as much as possible.
The company has also said Avastin works better with a specific type of chemotherapy, paclitaxel, and future studies would look at that combination. (Reporting by Anna Yukhananov. Editing by Michele Gershberg and Robert MacMillan)