BioCentury
ARTICLE | Regulation

Amyloid stands out among surrogate endpoints, and not in a good way: Data Byte

An analysis of five years of surrogate endpoints in accelerated approvals

June 19, 2021 2:09 AM UTC

Among the 15 surrogate endpoints upon which FDA has granted accelerated approvals in the last five and half years, β-amyloid clearance appears to be the most weakly supported.

Ninety nine (87%) of the 114 accelerated approvals granted in Jan. 1, 2016-June 18, 2021 were for cancer therapies, and nearly all them (72) used objective response rate (ORR), with a handful using progression-free survival (PFS) or lack of minimal residual disease. ...