FDA wants confirmatory trials to be underway before granting accelerated cancer nods, Pazdur says

The FDA’s oncology department, under the leadership of Richard Pazdur, M.D., is getting tougher on accelerated approvals for cancer drugs. When considering accelerated approvals for oncology therapies, the department wants to have a company’s confirmatory trial plan upfront, not after the therapy is already on the market, Pazdur said Thursday.