California based pharmaceutical company Genentech will be lodging an appeal with the US Food and Drug Administration and will be asking the regulator to allow it to conduct one more trial in order to prove that its drug, Avastin, can be used in treating breast cancer.
The FDA had withdrawn its approval for Avastin to be used in treating breast cancer and analysts believe that unless the agency reverses its decision, Genentech could lose as much as $1 billion in annual sales of the drug.
AdvertisementThe FDA will conduct a hearing on June 28 and June 29 to decide whether to allow Genentech some time to show evidence that the drug can be used in treating breast cancer. Avastin has also being approved to treat lung, colon, kidney and brain cancers and is estimated to bring in over $7.7 billion in annual sales.
FDA's Center for Drug Evaluation and Research (CDER) said that it was forced to remove its approval for Avastin as a breast cancer treatment after studies failed to show that the drug was clinically beneficial for the patients.
"To confirm the benefit to patients required for an accelerated approval, CDER expected to see a magnitude of benefit similar to the 5.5 month improvement in progression-free survival seen in E2100 or other real clinical benefit, such as improvement in quality of life or overall survival benefit. When the confirmatory studies failed to show a clinical benefit, CDER proposed that the breast cancer indication be withdrawn", CDER's Erica Jefferson said.
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