August 21, 2024, Freedom of Information Act Request / Expanded Access "Compassionate Use"
The request is to determine if a BLA was submitted to the FDA by Actinium Pharmaceuticals.
(a) the FDA Division of Hematologic Malignancies 1 (DHM1) Center for Drug Evaluation and Research Division of Hematologic Malignancies 1 (DHM1) 5901-B Ammendale Road, Beltsville, MD 20705-1266
(b) Information between October 2023 and August 2024
(1) The company Biologics License Application (BLA) number for 131 I-Apamistamab (Iomab-B)
(2) Historical timeline of events correlated with the BLA number for 131 I-Apamistamab (Iomab-B)
(2) Verification of receipt/acknowledgement of a BLA for 131 I-Apamistamab (Iomab-B) between January 2024 and August 2024.
(3) Complete response letter/opinion/proceedings for 131I-Apamistamab (Iomab-B) where the "FDA determined that the Phase 3
SIERRA trial is inadequate to support a BLA filing for Iomab-B" according to the company press release made on August 5, 2024.
(4) Dates and meeting minutes of Chemistry, Manufacturing and Controls (“CMC”) interactions with the FDA and company
(5) Dates and meeting minutes of Clinical/Non-Clinical interactions with the FDA and company
A response is estimated ~20 days from receipt: September 11, 2024.
However, 10 additional days can be added to the request if required.
Expanded Access / Compassionate Use
It is with the understanding that acceptance of the BLA also facilitates the way for Expanded Access or "compassionate use."
https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians
It was mentioned that Actinium Pharmaceuticals Chief Medical Officer was working to get the Expanded Access program started as early as 4Q2023. This was the same time that the BLA was planned to be submitted. However, the BLA was delayed to 1H2024 so that the company could complete CMC and clinical/non-clinical pre-BLA meetings with the FDA.
Congressional Support
A Congressional Inquiry has been submitted by a constituent from the Great State of Michigan to Representative Dan Kildee. It requests the following:
(1) the FDA Office of Oncologic Diseases (OOD) Divisions and Programs staff be audited as to why they would recommend such inhumane acts to determine more deaths vs. using the overwhelming positive survival data of Iomab-B from the past 8-year Actinium Pharmaceuticals, Inc. Phase III study.
(2) strongly encourage the FDA OOD to accept Actinium Pharmaceutical's Biologics License Application so that
(a) early access to Iomab-B can be given to patients now
(b) to allow the Oncologic Drugs Advisory Committee comprised of AML medical professionals to vote on the BLA for Iomab-B
A similar congressional inquiry was sent to Representative Jamie Raskin. He is a survivor of DLBCL which is another variation of non-Hodgkin lymphoma. https://raskin.house.gov/2023/4/an-open-letter-from-jamie-raskin-after-the-successful-completion-of-his-chemo-immunotherapy-treatment
For awareness, Actinium Pharmaceuticals is using Iomab-ACT + CAR-T to treat r/r DLBCL. This is important because Iomab-ACT is a lesser dosage of Iomab-B. In clinical studies, Iomab-ACT has shown favorable safety and efficacy with r/r DLBCL (RS) patients.