Actinium Pharmaceuticals has recently published new information from the U.S. Food and Drug Administration (FDA) regarding Iomab-B, a targeted radiotherapy designed to prepare patients for bone marrow transplants. Iomab-B is being evaluated for patients with acute myeloid leukemia (AML) that has either returned after initial treatment (relapsed) or has not responded to standard therapies (refractory). While the initial results were promising, the FDA has requested additional evidence before considering iomab-B for approval. In this article we’ll go over everything that you need to know.
Iomab-B is a new therapy that combines an anti-CD45 monoclonal antibody with a radioactive isotope, Iodine-131. You might also see it referred to as I-131 apamistamab. This type of therapy, called radioimmunoconjugate, is supposed to be more targeted towards leukemia cells since the radioactive isotope is directed to the cells that the antibody recognizes, in this case, those that express CD45 on their surface. Investigators hope that giving Iomab-B with reduced intensity chemotherapy (RIC) will get more patients into remission before undergoing allogeneic stem-cell transplant and that the remission will last longer than with chemotherapy-only induction.
The Phase 3 SIERRA trial included 153 patients with relapsed/refractory acute myeloid leukemia, the key findings were:
Despite the promising results, the FDA is requiring a new randomized clinical trial that better demonstrates a survival benefit. This new trial will be different from the SIERRA trial by not allowing patients to switch from the control group to the Iomab-B group, which should provide clearer data on the long-term effectiveness and safety of Iomab-B.
Actinium is currently in discussions with the FDA to finalize the design of this new trial. However, due to the significant investment required for such a study, Actinium has decided to seek a partner to help bring Iomab-B to market in the U.S. In the meantime, the company will focus on developing other therapies, such as Actimab-A, which is also a radioimmunoconjugate but targets CD33-positive cells. Actimab-A, also known as lintuzumab-Ac225, is in Phase 1/2 trials for patients with relapsed/refractory acute myeloid leukemia and is showing promising results so far.
While the delay in approval is disappointing, it’s important to understand that the FDA’s decision is driven by the need to ensure that new treatments are both effective and safe. The requirement for more data means that, if approved, Iomab-B will have been thoroughly evaluated to provide the best possible outcomes for patients.
Although Iomab-B’s availability may be delayed, Actinium and other companies' ongoing research and development efforts continue to offer hope for new and better treatments. Staying informed about these developments and discussing them with your healthcare provider is essential as you consider your treatment options.
If you are interested in keeping track of your labs, participating in or finding a clinical trial or discovering personalized treatment options, you can create a free HealthTree Cure Hub account!
Sources:
Actinium Pharmaceuticals has recently published new information from the U.S. Food and Drug Administration (FDA) regarding Iomab-B, a targeted radiotherapy designed to prepare patients for bone marrow transplants. Iomab-B is being evaluated for patients with acute myeloid leukemia (AML) that has either returned after initial treatment (relapsed) or has not responded to standard therapies (refractory). While the initial results were promising, the FDA has requested additional evidence before considering iomab-B for approval. In this article we’ll go over everything that you need to know.
Iomab-B is a new therapy that combines an anti-CD45 monoclonal antibody with a radioactive isotope, Iodine-131. You might also see it referred to as I-131 apamistamab. This type of therapy, called radioimmunoconjugate, is supposed to be more targeted towards leukemia cells since the radioactive isotope is directed to the cells that the antibody recognizes, in this case, those that express CD45 on their surface. Investigators hope that giving Iomab-B with reduced intensity chemotherapy (RIC) will get more patients into remission before undergoing allogeneic stem-cell transplant and that the remission will last longer than with chemotherapy-only induction.
The Phase 3 SIERRA trial included 153 patients with relapsed/refractory acute myeloid leukemia, the key findings were:
Despite the promising results, the FDA is requiring a new randomized clinical trial that better demonstrates a survival benefit. This new trial will be different from the SIERRA trial by not allowing patients to switch from the control group to the Iomab-B group, which should provide clearer data on the long-term effectiveness and safety of Iomab-B.
Actinium is currently in discussions with the FDA to finalize the design of this new trial. However, due to the significant investment required for such a study, Actinium has decided to seek a partner to help bring Iomab-B to market in the U.S. In the meantime, the company will focus on developing other therapies, such as Actimab-A, which is also a radioimmunoconjugate but targets CD33-positive cells. Actimab-A, also known as lintuzumab-Ac225, is in Phase 1/2 trials for patients with relapsed/refractory acute myeloid leukemia and is showing promising results so far.
While the delay in approval is disappointing, it’s important to understand that the FDA’s decision is driven by the need to ensure that new treatments are both effective and safe. The requirement for more data means that, if approved, Iomab-B will have been thoroughly evaluated to provide the best possible outcomes for patients.
Although Iomab-B’s availability may be delayed, Actinium and other companies' ongoing research and development efforts continue to offer hope for new and better treatments. Staying informed about these developments and discussing them with your healthcare provider is essential as you consider your treatment options.
If you are interested in keeping track of your labs, participating in or finding a clinical trial or discovering personalized treatment options, you can create a free HealthTree Cure Hub account!
Sources:
about the author
Jimena Vicencio
Jimena is an International Medical Graduate and a member of the HealthTree Writing team. She has a passion for languages and is currently learning Japanese. In her free time, she loves playing with her cats. Jimena is also pursuing a bachelor's degree in journalism.
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