FDA Clears Avastin for Breast Cancer

The bad news is-----

"Some insurers are reluctant to pay for Avastin's use among breast-cancer
patients, which can cost $100,000 for a year's supply."


FDA Clears Avastin for Breast Cancer

By MATTHEW PERRONE ­ 9 hours ago

WASHINGTON (AP) ? A Genentech drug received federal approval on Friday to
treat breast cancer, a surprise decision that could represent a shift in
standards for assessing the effectiveness of cancer medicines.

Going against the recommendation of its advisory panel, the Food and Drug
Administration judged the effectiveness of Avastin based on measurements of
tumor growth, not patient survival.

The ruling prompted a mixed reaction from both doctors and advocates for
breast-cancer patients.

Some bemoaned the lowering of medical standards, but others applauded the
federal government's endorsement of a drug that is already prescribed
"off-label" to an estimated 9,500 patients and for whom insurance coverage
is limited.

Avastin, which is already approved in the U.S. for treating lung and colon
cancer, was Genentech's best-selling product last year with revenue of $2.3
billion. Through a partnership with Genentech, Swiss drug maker Roche
markets the drug in Europe, where it had previously been approved as a
breast-cancer treatment.

Shares of Genentech Inc. rose $5.76, or 8 percent, Friday to $77.36 in after
hours trading.

FDA approval for drugs targeted at cancer patients who have never been
treated before is usually contingent upon data showing a drug extended, or
improved the quality of, patients' lives. Avastin showed neither in a study
submitted by Genentech, though the drug did slow tumor growth.

Wall Street analysts believe FDA's Avastin decision opens the door for more
cancer drugs to be approved for their tumor-shrinking capabilities ? a trend
that worries some health experts.

"If FDA sets a precedent of approving a drug based on progression free
survival, people are afraid they may stop looking at survival as the most
important endpoint," said Dr. Kay Dickersin, director of the Center for
Clinical Trials at Johns Hopkins University.

In December, a panel of outside FDA advisers voted 5 to 4 against
Genentech's application, indicating the drug's benefits did not outweigh
toxic side effects. Nevertheless, U.S. doctors continued prescribing it
"off-label," or without a federal endorsement.

Some insurers are reluctant to pay for Avastin's use among breast-cancer
patients, which can cost $100,000 for a year's supply.

Dr. Joseph Sparano of Montefiore Medical Center in New York said he
prescribes Avastin because it has shown better results at slowing breast
cancer growth than any other drug on the market.

The Y-ME National Breast Cancer Organization said the approval gives
patients an important new option.

"The benefits we're looking at here matter because they give patients hope,"
said Margaret C. Kirk, the group's chief executive. "Without disease
progression they may survive to see a discovery that can help them." they
may survive to see a discovery that can help them."

But the president of the National Breast Cancer Coalition said the decision
marked a lowering of standards for FDA. She argued that the drug's
effectiveness should not have outweighed safety risks, pointing to six
deaths attributed to the drug in the study submitted to FDA.

"All they had was progression-free survival in one trial, no increase in
quality of life and patient deaths in the Avastin group," said Fran Visco.
"We're very confused why FDA made this decision."

First approved in the U.S. to treat colon cancer in 2004, Avastin was the
first drug to fight cancer by blocking nutrients from reaching tumors.


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