Q+A-What is the status of Avastin in breast cancer?

WASHINGTON, Dec 16 (BestGrowthStock) – U.S. regulators have started
the process of revoking the approval of Roche Holding (ROG.VX: )
drug Avastin for treating breast cancer. European officials
also have recommended restrictions. [ID:nLDE6BF1T7]

WHAT IS THE STATUS OF AVASTIN FOR TREATING BREAST CANCER?

In the United States, the Food and Drug Administration has
started the process of removing breast cancer as an approved
use for the drug. The FDA says Avastin has not been shown safe
and effective for breast cancer patients.

The manufacturer, Swiss drugmaker Roche, is appealing the
FDA decision.

In Europe, officials recommended restricting Avastin in
breast cancer so it is given only in combination with a
chemotherapy called paclitaxel.

WILL THE DRUG STILL BE AVAILABLE?

Yes. Avastin will remain on the market and approved for
breast cancer while Roche’s appeal continues. The drug also is
cleared for treating colon, kidney, brain, and lung cancer and
will still be sold for those cancers regardless of the outcome
in breast cancer.

CAN THE DRUG STILL BE PRESCRIBED FOR BREAST CANCER IF THAT
USE IS REVOKED?

Yes. Doctors can prescribe Avastin to any patient they
think will benefit.

WILL U.S. INSURERS STILL COVER AVASTIN FOR BREAST CANCER?

It is unclear whether insurance coverage will continue.
Medicare, the federal health insurance program for the elderly
and disabled, will not change its current coverage while the
drug remains approved for breast cancer, the FDA said. Private
U.S. insurers also may keep paying for now, but they are
unlikely to continue if the breast cancer use is officially
rescinded.

HOW MUCH DOES AVASTIN COST?

The medicine costs about $8,000 a month for breast cancer
patients. Roche caps the annual price tag at $57,000 per
patient.

DOES AVASTIN HELP BREAST CANCER PATIENTS?

In four studies, Avastin failed to extend the lives of
breast cancer patients. The drug did lengthen the time it took
cancer to grow by as much as 5.5 months in one study. That
means cancer looked the same on patient scans during that time,
but no improvement in symptoms was seen for patients on
average.

While some women report improvements with Avastin, it is
difficult to tell outside of clinical trials whether the drug,
another treatment or some other factor was responsible. The FDA
said it is open to any new research that can identify specific
types of women likely to benefit.

IS THE DRUG DANGEROUS?

Avastin carries life-threatening risks such as bleeding,
heart attacks and holes in the stomach and intestines.

WHAT HAPPENS NEXT?

Roche unit Genentech said it will request a hearing to
contest the U.S. decision. There is no set timetable for how
long the FDA will take to schedule a hearing and make a final
decision.

WHY DID THE DRUG GET APPROVAL IN THE FIRST PLACE?

The FDA approved Avastin for breast cancer under a shorter
process meant to get important treatments to patients quickly.
Under that process, drugmakers are required to run additional
tests to confirm early indications of benefit. If later tests
fail, the FDA can revoke the approval.

HOW DOES AVASTIN WORK?

Avastin, known generically as bevacizumab, is a monoclonal
antibody, a targeted drug that homes in on newly growing blood
vessels. It was one of the earliest drugs in a class called
angiogenesis inhibitors, which stop tumors from growing
themselves a nourishing blood supply.
(Editing by Gerald E. McCormick)

Q+A-What is the status of Avastin in breast cancer?