FDA Outlines “Expedited” Review For Breakthrough Therapies; “Hyper-Fast” Reviews, Beyond Oncology
This article was originally published in RPM Report
Oncology drug sponsors have gotten used to a “faster-than-Priority” timeline for breakthrough products. Now, FDA is outlining a formal process for its reviewers to use for any “Breakthrough” designated therapy with life-saving potential.
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FDA is close to hitting a milestone in the short history of the Breakthrough Therapies designation: 50 indications approved under the abbreviated development and review pathway. In reflecting on the last three-plus years, agency officials say the quality of requests for Breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
Patient-reported outcomes in oncology clinical trials remain an infrequently used tool, despite acknowledgement by sponsors that the patient experience is important to measure – and encouragement from FDA officials to do so. The lack of PROs in oncology may be a byproduct of the fast pace of cancer drugs are developed in the U.S.: small trials and accelerated pathways.
It’s a question FDA has heard on Capitol Hill throughout the 21st Century Cures process: Why can’t all drug review divisions keep pace with the approvals seen in the oncology office – and shouldn’t steps be taken to ease development pathways for “lagging” conditions like Alzheimer’s and rare diseases? In the face of a tougher “Cures” debate in the Senate, FDA issues a white paper to more fully outline its response.