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UK rejects Roche's Avastin as U.S. verdict looms

Last Updated: 2010-12-08 9:52:16 -0400 (Reuters Health)

By Ben Hirschler

LONDON (Reuters) - Britain's healthcare cost agency NICE has rejected Roche's Avastin as a treatment for advanced breast cancer and given a poor assessment of the drug ahead of a decision soon on its status in the key U.S. market.

The rebuff from the National Institute for Health and Clinical Excellence (NICE) is no great surprise, since Avastin has already been rejected for bowel cancer. But the negative comments will highlight uncertainty about its use elsewhere.

"Unfortunately, we did not receive any evidence from the manufacturer to show that bevacizumab (Avastin) can significantly lengthen a patient's life or, importantly, offer a better quality of life than existing treatments," NICE Chief Executive Andrew Dillon said.

Although clinical data seemed to show Avastin might slow the growth and spread of cancer, NICE said on Wednesday the size of this effect varied between studies and it was "extremely unclear" that the benefits translated into longer life.

Roche said it was disappointed NICE had rejected Avastin, despite evidence from a new meta-analysis showing some women with difficult-to-treat breast cancers could derive substantial benefit from adding Avastin to their chemotherapy.

NICE said the new evidence was not robust for these patients, who had previously received taxane chemotherapy or had so-called "triple negative" disease.

The total average cost of treating a patient with Avastin plus chemotherapy is more than 33,000 pounds ($52,000), according to calculations by Roche.

The final draft guidance from NICE -- the body responsible for deciding which treatments are paid for on Britain's state health service -- is now subject to appeal.

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency are currently reconsidering Avastin's license as a treatment for metastatic breast cancer.

An FDA advisory panel recommended removing the drug's current approval for breast cancer in July. There is no set timeline for an FDA ruling on whether to revoke the breast cancer approval, although the U.S. agency is due to decide on Avastin's use with other chemotherapies by Dec. 17.

If the FDA pulls it, the drug would remain on the market with clearance for bowel, lung, brain and kidney cancers.

About $1 billion of Avastin's sales come from breast cancer uses, analysts estimate, and the product was Roche's top-selling drug in 2009, with sales of some $6 billion.

Avastin was once tipped to become the world's biggest selling drug by 2014, but its prospects have faded after doubts over its benefits in breast cancer and after it failed in clinical trials for prostate and stomach cancer.

The challenges facing the medicine have shaken confidence in Roche's growth prospects, contributing to a fall in its stock price of around one fifth this year.

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