WASHINGTON (AP) -- The Food and Drug Administration has granted Swiss drug maker 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.
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.
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.