Roche’s blockbuster cancer drug Avastin has been spurned once again by Britain’s health cost watchdog NICE, this time as a treatment for breast cancer.

The National Institute for Health and Clinical Excellence (NICE) said on Friday it was rejecting the drug for patients whose breast cancer has spread to other parts of the body due to “uncertain evidence.”

Avastin, whose generic name is bevacizumab, is also licensed as a treatment for a number of other cancers — but it has not been approved by NICE for use in any of these.

It is widely used for treating bowel, lung, breast and kidney cancer in other countries and had worldwide sales of 6.2 billion Swiss francs ($5.90 billion) last year.

Draft guidance from the agency, which decides if drugs should be paid for by the country’s taxpayer-funded National Health Service (NHS), concluded that evidence on Avastin did not show it significantly improved or extended lives in breast cancer.

“The clinical trial results for bevacizumab were disappointing in that they were unable to prove definitively that the drug could extend the lives of patients with metastatic breast cancer over and above currently available treatments,” said NICE Chief Executive Andrew Dillon.

The NICE ruling comes ahead of a Food and Drug Administration advisory panel meeting on Avastin on July 20, when experts will consider whether or not to endorse full approval of the medicine in breast cancer in the United States.

Roche said its drug, when added to chemotherapy, had been shown to reduce the risk of a woman’s disease progressing by half and it would work with the British government to explore all possible ways of making Avastin available to patients.

A company spokeswoman said Roche had submitted a patient access scheme to NICE, which would place a cap on the amount the NHS would pay for the treatment of each woman. The plan has not yet been included in NICE’s evaluation as it is still pending approval from the Department of Health.

NICE also decided in separate draft guidance not to recommend Takeda’s bone cancer drug Mepact, or mifamurtide, because of uncertainties over its effectiveness and its high cost.

Source: Reuters

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Mark Thornton, a former medical officer at the FDA and current president of the Sarcoma Foundation of America, uses the recent Provenge approval to illustrate why the FDA needs to reverse its position on the cancer drug Mepact.

Back in 2007 the FDA decided that both Provenge and Mepact should go back to the clinic for a new study. Dendreon was able to afford that because it was pursuing a mega-blockbuster approval for prostate cancer. But the developers of Mepact were essentially asked to go back to the drawing board and recruit virtually every sarcoma patient in the U.S. in order to get the data it needed to qualify for an approval.

“Imagine if a clinical trial for a new asthma or diabetes drug required every single patient in the country to be included not once but twice and you will begin to appreciate the profound predicament those of us in the rare-disease community face when it comes to the FDA’s irrational standards,” writes Thornton in an op-ed piece in the Wall Street Journal. He goes on to encourage the new FDA commissioner to develop the kind of creative regulatory pathway that Europe has in place for new drugs that treat rare diseases. And he called on the FDA to make a rapid u-turn and approve Mepact immediately.

IDM Pharma had developed Mepact. Japan’s Takeda bought IDM a year ago and handed control of the Mepact program over to its U.S. cancer subsidiary, Millennium: The Takeda Oncology Company.

Source: FierceBiotech

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