Thanks for sharing Targeted Oncology and Sabrina S.! Obviously a significant milestone for MRD (and likely a sign of things to come for other tumor types) . . . More to come later but for for now, here's a link to the meeting information and materials: https://lnkd.in/gMeHzXzN Some interesting tidbits from the article: [FDA representatives] "confirmed that . . . there was a strong individual-level association for PFS and OS, but trial-level associations were weak to moderate in disease subpopulations for PFS and were generally weaker for OS." And "a strong trial-level association could become a validated surrogate end point and support regular approval; however, very few oncology end points have met this standard, and most end points that support accelerated approval have not been assessed for trial-level surrogacy or have weak trial-level associations." #fda #mrd #acceleratedapproval #multiplemyeloma
In a 12 to 0 vote, the FDA’s Oncologic Drug Advisory Committee decided that evidence supported that minimal residual disease (MRD) could be used as an accelerated approval end point in clinical trials of multiple myeloma. https://ow.ly/r1SU50RfkJz