FDA Draft Guidance Outlines ‘One-Trial’ Approval Process For Oncology Drugs

FDA signals in a new draft guidance that using the same clinical trial population for both accelerated and full approval applications and relying on surrogate endpoints data for both steps could become more common. Although the draft applies only to oncology products, the same process has been used for other drugs, including the Alzheimer’s medication Leqembi (lecanemab), produced by Eisai, Inc. and Biogen; after receiving accelerated approval in January, the sponsors are seeking full approval based on later surrogate endpoints...