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Roche’s Avastin Rejected by U.K. for Use in Breast Cancer

Roche Holding AG’s Avastin doesn’t meet cost criteria for extending the lives of breast-cancer patients when combined with the chemotherapy drug capecitabine, and shouldn’t be used as a first-line treatment, the U.K. medical-spending regulator said.

An appraisal by the National Institute for Health and Clinical Excellence found it was unclear whether Avastin, also known as bevacizumab, extended overall survival and improved patients’ quality of life more than capecitabine alone, the agency said today in a statement.

The regulator advises the National Health Service on which treatments represent value for money as part of the state health-care provider’s decisions on drug purchases. Based on the assessment, Avastin probably isn’t worth the average monthly cost to the NHS of about 3,689.12 pounds ($5,874.55) per patient, NICE said.

“We understand the need for effective treatments that can help patients live for as long as possible with a good quality of life,” Andrew Dillon, chief executive officer of London-based NICE, said in the statement. “However, the evidence submitted to our independent appraisal committee did not conclusively show that bevacizumab could do either.”

Avastin also failed to win the backing of NICE last year for the treatment of breast cancer that has spread when combined with paclitaxel, another chemotherapy. The agency’s final guidance on Avastin with capecitabine, sold by Roche as Xeloda, will be published in August.

"This draft guidance is not the final recommendation from NICE," Roche said in an e-mailed statement. "Roche is committed to working with NICE and will respond to the draft guidance."

NICE compared Avastin and capecitabine with capecitabine and a placebo. While Avastin halted progression of the disease for 2.9 months longer than the chemotherapy alone, it was unclear if the drug extended patients’ lives, NICE said.

The decision follows a U.S. Food and Drug Administration move in November to revoke approval of Avastin as a treatment for metastatic breast cancer. Avastin, with 5.29 billion Swiss francs ($5.78 billion) in 2011 sales, didn’t extend lives and triggered side effects including high blood pressure and bleeding when used for the disease, the FDA said on Nov. 18. The drug remains approved in the U.S. for colon, lung, kidney and brain cancer.

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