Full Trial Results Published
The full trial results of Iomab-B have been published in the Journal of Clinical Oncology. Of notable interest was the comparison of patients at January 2024 that were alive who received Iomab-B vs the control.
https://ascopubs.org/doi/10.1200/JCO.23.02018
FDA Freedom of Information Act Request Update
The initial FDA response:
The Food and Drug Administration (FDA) has completed processing your August 13, 2024, Freedom of
Information Act (FOIA) request, in which you sought:
(1) Biologics License Application (BLA) number for 131I-Apamistamab (Iomab-B)
(2) Complete response 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 Clincal/Non-Clinical interactions with the FDA and company
The FDA can neither confirm nor deny the existence of records that would be responsive to your request. Such records, if they existed, would be considered confidential commercial information.
5 CFR § 294.112 - Confidential commercial information
(a) In general, OPM will not disclose confidential commercial information in response to a Freedom of Information Act request except in accordance with this section.
(b) The following definitions from Executive Order 12600, apply to this section:
(1) Confidential commercial information means records provided to the Government by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), because disclosure could reasonably be expected to cause substantial competitive harm.
(2) Submitter means any person or entity who provides confidential commercial information, directly or indirectly, to OPM. The term includes, but is not limited to, corporations, state governments, and foreign governments.
An appeal to the FDA response is underway since the information being requested is from the FDA and not the submitter (Actinium).
The submitter (Actinium) of the requested information has been lawfully published in SEC reports/medical journals and officially made available to the public in press releases by the company.