The Food and Drug Administration has granted Swiss drugmaker Roche a first-of-a-kind public hearing to defend the effectiveness of its drug Avastin for treating breast cancer, just months after the agency ruled that the drug is ineffective for that use.
Roche said Thursday it will make its case at the two-day hearing in June for keeping the drug approved for treating recurring breast cancer.
Avastin is the world's best-selling cancer drug and is also approved for several types of colon, lung, kidney and brain cancer. Those uses have not been questioned by the FDA.
In December, the FDA ruled that recent studies failed to show that Avastin significantly extended or improved breast cancer patients' lives. The agency began proceedings to revoke the drug's approval for treating breast cancer, but Roche took the rare step of challenging the decision.
Drug companies almost always follow FDA requests, and the meeting starting June 28 over the fate of Avastin will be the first of its kind.
"We believe Avastin is an important option for women with this disease and should remain an FDA-approved choice," said Roche Chief Medical Officer Hal Barron, in a statement.
A spokeswoman for the non-profit Breast Cancer Action group said the meeting could be productive if it leads to reforms in how the FDA reviews and approves cancer drugs.
"But if this is just going to be about Roche buying their way into the FDA and putting profits before patients, then I think this meeting is going to be highly questionable," said Angela Wall, communications manager for the San Francisco-based advocacy group.
Avastin was Roche's best-selling product last year with global sales of $6.8 billion. But the company slashed sales expectations for the drug by more than 20 percent following the FDA's move, which has already led to a downturn in prescribing by doctors.
The FDA approved Avastin for breast cancer in 2008 based on one study suggesting it halted the spread of breast cancer for more than five months when combined with chemotherapy. But follow-up studies showed that the delay lasted no more than three months, and patients suffered dangerous side effects, including hypertension and blood clots.
Dr. Diana Zuckerman said Thursday that the FDA is holding more public meetings in an effort to be more transparent. Critics have long criticized the agency for being too secretive on decisions that affect public health.
"While transparency is important, in this case it results in delays that are likely to harm breast cancer patients," said Zuckerman, who directs the non-profit National Research Center for Women & Families. Zuckerman said physicians should advise their patients that Avastin's risks outweigh its benefits for breast cancer.
The FDA's review of Avastin has generated passionate debate among doctors, patients and even politicians.
An outside panel of cancer doctors voted almost unanimously last year that the drug's benefits do not outweigh its risks for breast cancer patients. But some patients credit their survival to Avastin and say the FDA's decision could amount to a death sentence.
Adding to the debate is Avastin's high cost, which some politicians argue is the real motivation behind FDA's decision against the drug. The agency has rejected that claim, noting it is legally barred from considering cost when deciding which therapies to approve for use.
When infusion charges are included, a year's treatment with Avastin can run more than $100,000, though Roche caps spending at $57,000 per year for patients who meet certain financial criteria.
The drug remains available for patients, as most insurers are still paying for its use against breast cancer..
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