FDA recommendation according to Actinium's August 5, 2024 Press Release is:

Iomab-B + fludarabine + total body irradiation

vs.

Cyclophosphamide + fludarabine + total body irradiation

Why would the FDA recommend a post-transplant vs. pre-transplant comparison when the drugs address different factors that affect HCT outcomes?

KOL Call with Dr. Sergio Giralt
- Iomab-B Pre-Transplant demonstrated that disease status (durable complete remission), cytogenetic risk, circulating blasts <25%, and Karnofsky performance all favored Iomab-B
https://d1io3yog0oux5.cloudfront.net/_19aa525aa30da9f072ecb2367dfa6e7e/actiniumpharma/db/206/1114/pdf/Giralt_SIERRA+KOL+Event_FINAL_02.28.2023+Giralt.pdf

https://www.vjhemonc.com/video/avdcc6si11g-lba-sierra-results-iomab-b-prior-to-allogeneic-transplantation-vs-conventional-care-in-rr-aml/

Post-Transplantation Prophylaxis Resulted in Similar Outcomes for Mismatched and Matched Donor Stem Cell Transplants
- Cyclophosphamide Post-Transplant demonstrated similar overall survival between unrelated, matched vs. unrelated mismatched when Cyclophosphamide was used.
https://www.mskcc.org/clinical-updates/post-transplantation-prophylaxis-resulted-in-similar-outcomes-for-mismatched-and-matched-donor-stem-cell-transplants

The goal should be to minimize the Duval factors to 0 score which translates to a higher overall survival probability with the bone marrow transplant.

Perhaps Memorial Sloan Kettering Cancer Center should weigh in to see if such a trial is necessary?