* U.S. sets Thursday briefing on breast cancer use
* Europe also could rule on Thursday
* Patients, lawmakers lobby FDA on Avastin
* $1 billion in sales at risk for Roche
* Roche shares down 0.5 pct
(Updates with FDA briefing, stock activity)
By Lisa Richwine
WASHINGTON, Dec 15 U.S. health officials are
set to announce their decision on whether Roche's ROG.VX top
selling drug should be used to treat breast cancer, a ruling
that places $1 billion in company sales at risk.
The Food and Drug Administration set a media briefing
slated for 11 a.m. ET (1600 GMT) on Thursday on Avastin's use
in advanced breast cancer.
An advisory panel urged the agency in July to remove breast
cancer as an approved use after studies failed to show the drug
extended survival or improved symptoms. The FDA usually follows
The European Medicines Agency also may rule on Thursday at
a monthly meeting of experts.
Avastin is the world's best-selling cancer medicine and one
of the most expensive, a fact that fuels controversy. If the
breast cancer approval is removed, the drug would remain
available for treating bowel, lung, brain and kidney cancers.
Doctors could still prescribe it for breast cancer, but
insurers would be unlikely to pay the $8,000-a-month price
The case has split patient advocates, and some lawmakers
have accused the agency of trying to limit access to an
expensive treatment. The FDA is not allowed to consider cost in
Britain already refuses to pay for Avastin for advanced
breast cancer. The country's healthcare cost agency last week
gave the drug a poor assessment. [ID:nLDE6B71VI]
Industry analysts estimate Roche could lose $1 billion of
its $6 billion in annual sales if Avastin loses its U.S. and
European licenses for breast cancer. Doctors could still
prescribe the drug for breast cancer patients, but insurers
would be unlikely to cover it without FDA approval.
Roche could request a hearing and appeal any FDA decision
to remove the breast cancer use.
The company argues Avastin provides meaningful benefits for
patients with few choices for fighting an advanced cancer.
"We continue to believe Avastin should be an option" for
women with advanced breast cancer, said Charlotte Arnold, a
spokeswoman for Roche unit Genentech.
Roche has an application pending with the FDA seeking
approval of Avastin as a second-choice treatment for advanced
breast cancer after initial therapy fails. The deadline for
that decision is May 19.
Shares of Roche were down 0.5 percent at 140.50 Swiss
(Editing by Steve Orlofsky and Lisa Von Ahn)