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Accelerated Approval: Mend, Don't End, Pazdur Tells ODAC After Avastin
Accelerated Approval: Mend, Don't End, Pazdur Tells ODAC After Avastin
D Gingery
20100626
2010 Jul 26
The Pink Sheet Daily
Accelerated Approval: Mend, Don't End, Pazdur Tells ODAC After Avastin
The Pink Sheet Daily. 2010 Jul 26, D Gingery
Genentech's Avastin may not have produced a storybook ending in metastatic breast cancer, but it still serves as an example of how the accelerated approval process can work. As Oncologic Drugs Advisory Committee members were preparing to vote 12-1 in favor of removing the breast cancer indication for the drug, Richard Pazdur, director of FDA's Office of Oncology Drug Products, still had to tell them the vote would not confirm the agency made a mistake."Let me absolve you of your guilt," Pazdur said...