FDA officials said questions about the expedited approval of the PD-1 and PD-L1 drugs have been largely resolved, in part thanks to advice from the Oncology Drug Advisory Committee.
Last year, the agency focused on 10 indications for the PD-1 and PD-L1 drugs that received expedited approvals, but failed to show patient benefit in confirmatory trials. Nine of the 10 original fast-track approvals – dubbed âpending indicationsâ by the agency – were based on single-arm studies that produced low response rates.
If a clinical trial does not meet its endpoints, the drug should be evaluated as part of the treatments available for the indication.Richard Pazdur
Fast Track Approval Allows FDA to Extend Benefit of the Doubt on an Indication Based on an Interim Endpoint Seen as “Reasonably Likely to Predict” Patient Benefit, and Now Following PD Drug Review -1 and PD-L1, the agency appears to have soured over expedited approvals based on single-arm studies producing poor response.