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Swiss pharmaceutical Roche has been granted a unique opportunity to make a case publicly about the effectiveness of its drug Avastin for treating breast cancer.
Roche will use the occasion to try and convince the US Food and Drug Administration that it was wrong to rule the drug is ineffective.
The drug maker will use the two-day hearing to defend the drug approved for treating recurring breast cancer.
Avastin is also approved for several types of brain, kidney, lung and colon cancer. The FDA has not questioned those uses of Avastin, which is the best-selling cancer drug in the world.
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.
Copyright © Press Association 2011