Submitted: September 24, 2024
On November 8, 2024, there were 69 appeals ahead of the FOIA appeal submitted to the FDA on Iomab-B.
On January 7, 2025, there were 59 appeals ahead of the FOIA appeal submitted to the FDA on Iomab-B
37 business days have transpired to process 10 appeals. With 218 days estimated to process 59 appeals at the current rate, and 248 business days remaining since the January 7th update, this suggests a response is expected by November 12, 2025.
Summary of Request:
(1) Biologics License Application (BLA) number for 131I-Apamistamab (Iomab-B)
(2) Complete response letter or (update) Refusal to File letter for 131I-Apamistamab (Iomab-B) where
the "FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B"
(3) Dates and meeting minutes of Chemistry, Manufacturing and Controls (“CMC”) interactions with the FDA and company
(4) Dates and meeting minutes of Clinical/Non-Clinical interactions with the FDA and company
Separately, a worthwhile read on understanding the direction of AML was published in Blood Journal in September 2024 by Dr Kantarjian, one of the lead doctors studying AML at MD Andersen. At the end, he reiterates Iomab-B which was also mentioned in his 2021 AML published article. The 2024 article in comparison to 2021 serves as an update.