Aetion Discusses RWE in FDA’s Review of Multiple Myeloma Drug

The Food and Drug Administration (FDA) approved ABECMA for use in patients with relapsed or refractory multiple myeloma. The FDA noted several issues regarding the submitted real world evidence (RWE).

“The Agency found the RWE study to be inconclusive. FDA noted a number of issues with the RWE study, including missing data, differences in follow-up and response assessment, population heterogeneity, and bias in endpoint assessment.” Read more here.

(Source: Nick Honig and Jennifer Polinski, FDA Decision Alerts, Aetion, 7/19/21)