US FDA removes approval of avastin for breast cancer

[Lani]

How will we ever determine if there is a subset of bc for which avastin's effectiveness/cost vs side effects justify its use just because it doesn't do so against bc as a whole?

Dr. Slamon said herceptin would not have been approved had they not found that FISH testing identified those likely to respond, as when tested in ALL bc patients it was not statistically effective.


WASHINGTON—The U.S. Food and Drug Administration said Thursday it is recommending that Avastin no longer be approved for treatment of breast cancer.

The FDA's move contrasted with a decision announced simultaneously by the European Medicines Agency, which said it will keep its approval for Avastin's use in breast cancer in combination with a chemotherapy drug.

Avastin, sold by Roche Holding AG, is one of the company's top-selling medicines, with sales of about $6 billion globally in 2009. Analysts have said that breast-cancer treatments account for about $1 billion of that amount.

Avastin is used for other cancers, including colon, lung, brain and kidney cancer. FDA approval for those conditions wasn't affected by Thursday's announcement.

"After careful review of the clinical data, we are recommending that the breast-cancer indication for Avastin be removed based on evidence from four independent studies," said Janet Woodcock, the FDA's top drug regulator, in a written statement.

Hal Barron, chief medical officer at Roche's Genentech unit, which sells the medicine in the U.S., said the company is pleased that European regulators "confirmed the benefits of Avastin." Women with breast cancer in the U.S. "should also have Avastin as a treatment option," he said.

Genentech said it will request a public hearing to contest the FDA's determination. The FDA said the Avastin label will stay the same for now as the challenge is considered.

The FDA gave Avastin accelerated approval to treat metastatic breast cancer in 2008, when data suggested that the drug delayed progress of the disease by more than five months.

But in July this year, an FDA advisory committee voted to recommend that the agency rescind the approval. The committee acted after reviewing new studies that show a smaller impact on progression-free survival of less than a month to 2.9 months depending on the treatment group.

The studies also showed more side effects, such as bleeding, among women being treated with Avastin. The studies failed to show that the drug significantly extended the life span of patients.

"The limited effects of Avastin combined with the significant risks led us to this difficult decision," said Dr. Woodcock.

Since the July advisory committee meeting, thousands of women have petitioned Congress and the FDA not to withdraw the approval for breast-cancer treatment.

Several major patient advocacy groups have also lobbied the agency and Capitol Hill to keep the approval in place.

After the FDA's decision, doctors could still prescribe Avastin "off-label" for breast cancer since the drug remains on the market as an approved treatment for other cancers, but insurers might not cover the breast-cancer usage.

[hutchibk]

"The studies failed to show that the drug significantly extended the life span of patients."

Gee, I wonder what the FDA considers "significantly" ~ for anyone who is fighting for every day they can get to spend with their kids, etc... several extra weeks or months might be tremendously significant. You think?

[tricia keegan]

I'm sorry to read this sad news

[gdpawel]

Dr. Robert Nagourney is medical and laboratory director at Rational Therapeutics, Inc., in Long Beach, California, and an instructor of Pharmacology at the University of California, Irvine School of Medicine. He is board-certified in Internal Medicine, Medical Oncology and Hematology. His take on this Avastin controversy is interesting.

There are no perfect drugs. There are simply drugs that work for certain patients. VEGF down-regulation is an attractive and highly appropriate therapy for a subset of cancer patients with many different diagnoses whose tumors use the VEGF pathway to their advantage. Avastin combined with carboplatin and taxol has improved the survival of lung cancer patients. Avastin plus folfox has improved survival for colon cancer patients. Avastin plus chemotherapy improves the survival of some breast cancer patients. The problem is that it doesn't improve the survival of all breast cancer patients.

When the FDA rules on the clinical utility of a drug, they use a broad-brush approach that looks at the global outcomes of all patients, determining whether these glacial trends reflect a true climate change. The problem is that while Bethesda, Maryland may not be noticing significant changes in ocean levels, people who live on the Maldives are having a very different experience. As these scientists ponder the significance of Avastin, some breast cancer patients are missing out on a treatment that could quite possibly save their lives.

One breast cancer patient's life saving therapy is another's pulmonary embolism without clinical benefit. Until such time as cancer patients are selected for therapies predicated upon their own unique biology, we will confront one Avastin after another. Our solution to this problem has been to investigate the VEGF targeting agents in each individual patient's tissue culture, alone and in combination with other drugs, to gauge the likelihood that vascular targeting will favorably influence each patient's outcome. Our results to date in patients with non-small cell lung cancer, colorectal cancer and even rare tumors (like medullary carcinoma of the thyroid) suggest this to be a highly productive direction for future development.

[StephN]

See the following thread for information after the "stakeholders" conference call with Genentech panel.

http://her2support.org/vbulletin/sho...116#post241116