Appeal Update October 1, 2024.

The basis of your appeal is summarized below:
Glomar / Exemption 3 & 4

Pursuant to 5 U.S.C. § 552(a)(6)(B)(i) and 5 U.S.C. § 552(a)(6)(B)(iii) of the FOIA and 45
CFR 5.24(f) of the HHS FOIA regulations, your appeal falls under “unusual circumstances” in that our office will need to consult with another office with a substantial interest in determining the appeal. The actual processing time will depend on the complexity of the issues presented in the appeal.

Iomab-B Clinical Trial Results Published 

The full Iomab-B trial results were published in the Journal of Clinical Oncology. Below are key excerpts:

A crossover design was deemed essential to provide best patient care and facilitate accrual. 

In crossover studies, Event Free Survival is a more reliable indicator of response than OS because it is not confounded by crossover or subsequent AML therapies.

The crossover design precluding assessment of the true impact of 131I-apamistamab on survival was a study limitation that led to prespecified exploratory analyses within the conventional care group and post hoc OS analyses with crossover patients excluded from the conventional care group. These findings suggested that survival may be improved with the 131I-apamistamab–led regimen compared with conventional care.

The optimal therapy for patients with RR AML has not been established. A subset of patients achieve long-term remission with alloHCT. However, few older patients with RR AML are offered alloHCT, and SIERRA was designed to address this unmet need.

Memorial Sloan Kettering Cancer Center 

Dr. Sergio Giralt, Deputy Division Head, Division of Hematological Malignancies and Attending Physician, Adult BMT Service at the Memorial Sloan Kettering Cancer Center, and leading SIERRA Trial investigator and corresponding author, said, "The SIERRA trial was important for the field of transplant and demonstrated for the first time in a randomized study that the CD45 antibody-radioconjugate Iomab-B can provide patients with improved access to a potentially curative hematopoietic stem cell transplant, and improved outcomes compared to current chemotherapy-based regimens. Importantly, Iomab-B demonstrated a statistically significant improvement in key efficacy endpoints including durable Complete Remission and event-free survival. The SIERRA trial was conducted as multiple new therapies gained approval and was designed to address the nuances and difficulty of treating this patient population including allowing physician's choice of care in the control arm given the heterogeneity of treatment across institutions and the crossover design to provide best patient care. Despite multiple drug approvals for patients with AML, there remain no curative options for older patients with relapsed or refractory disease, and outcomes for these patients also remain dismal. My fellow investigators and I are disappointed that the SIERRA trial will not support the approval of Iomab-B despite the positive results and significant unmet medical needs of this patient population. However, there is continued significant interest from the transplant community to participate in the upcoming phase 3 study with Iomab-B to provide patients access to this important drug candidate."

On August 05, 2024, Actinium announced that after concluding both its clinical and Chemistry, Manufacturing and Controls ("CMC") interactions with the FDA regarding the BLA pathway for Iomab-B, the FDA determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing, and the SIERRA trial alone will not be adequate for BLA filing.

Thoughts

- Actinium Pharmaceuticals released many of the people associated with a BLA.

- Actinium Pharmaceuticals is looking for a strategic partner following FDA interactions to take on Iomab-B in the USA.

- If the results of the FDA FOIA Appeal support a follow-on FDA Citizen's Petition, it will assist the strategic partner to get patients to Iomab-B Early Access now and the BLA filed with the FDA sooner. Efforts by the petition participants become beneficial to raise awareness on Early Access and help others seek enrollment to Early Access.
 
- If the strategic partner and medical community support a new trial in lieu of petition, it will at least give patients access to Iomab-B in the trial now. Efforts by the petition participants become beneficial to raise awareness of the new trial and help others seek enrollment to the trial.