Approval for Avastin for breast cancer dropped

The U.S. Food and Drug Administration announced Thursday it was withdrawing its approval of the drug Avastin to treat advanced breast cancer, a decision that came as a blow to some cancer patients fighting the disease.

"We are recommending that the breast cancer indication for Avastin be removed, based on evidence from four independent studies," Dr. Janet Woodcock, director of the FDA's drug evaluation and research division, said. "None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects."

Ushered into cancer therapy on a wave of promise six years ago because it chokes off a tumor's blood supply, Avastin has been used successfully to treat several forms of cancer: colorectal, lung, and brain tumors. It's recognized as the best-selling cancer medication in the world.

But Avastin has been embroiled in a fierce debate over its use for advanced breast cancer, and arguments have touched on hot-button issues in medicine: patients' rights and high-flying costs.

While some women have died while on Avastin, others - so-called super-responders - have thrived on it. Avastin can cost $88,000 a year. Drugmaker, Genentech, a division of Roche, caps costs at $57,000 for people earning under $100,000 a year. The company is appealing the FDA's decision.

Former Long Beach resident Patricia Howard, who retired recently and moved to Florida after 21 years as a Smithtown art teacher, has become one of the country's most vocal advocates for the drug, having participated in a vigorous letter-writing campaign to continue Avastin's use.

"I am devastated," said Howard, 65, who has had advanced breast cancer since 2006. Advanced breast cancer is incurable but can be kept under control with treatment.

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Howard, also takes a chemotherapeutic pill, Xeloda, to keep the disease at bay. She's infused with Avastin every three weeks and said she had hoped to continue receiving it for the rest of her life. After she began Avastin in 2008, tumors that had spread to the lining of one lung vanished.

Now, Howard doubts her insurers - Medicare and a private carrier - will continue footing the bill. "I get infused with this drug every three weeks," Howard said. "It's my lifeline."

Susan G. Komen for the Cure, an advocacy group, is asking insurers to continue coverage for women who are benefiting.

However, Dr. Lora Weiselberg, chief of the breast cancer service at the North Shore-Long Island Jewish Health System, said the risk/benefit ratio for Avastin doesn't support its use.

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"Side effects can be potentially devastating," Weiselberg said of hypertension, kidney failure, hemorrhaging and abnormal blood clotting.

Earlier this year, Dr. Shenhong Wu of Stony Brook University's medical school, found Avastin can produce kidney damage. Last year, his research showed Avastin can cause intestinal perforations.

The FDA had conditionally approved Avastin for advanced breast cancer in 2008. An expert panel in July recommended the agency rescind that.