Actinium to Pursue Additional Clinical Trial for AML Radioactive Drug Following FDA Request

FDA Request for New Trial::

The FDA has determined that the phase 3 SIERRA trial conducted by Actinium Pharmaceuticals is not adequate to support a BLA (Biologics License Application) filing for Iomab-B, a radioactive drug intended for the treatment of acute myeloid leukemia (AML).

Iomab-B Overview::

Iomab-B is a targeted radioimmunotherapy designed to deliver a lethal dose of radiation directly to cancer cells while minimizing the impact on healthy cells.

Clinical Trial Details::

The SIERRA trial aimed to evaluate the efficacy and safety of Iomab-B in patients with relapsed or refractory AML. Despite the trial's completion, the FDA has requested additional data, necessitating another clinical trial.

Actinium's Response::

Actinium Pharmaceuticals will need to conduct an additional clinical trial to provide the FDA with the required data to support the approval of Iomab-B. This decision follows the FDA's assessment that the current trial data is insufficient.

Context of AML Treatment::

Acute myeloid leukemia (AML) is a rapidly progressing cancer that forms in the bone marrow, resulting in an increased number of white blood cells in the bloodstream. The FDA has approved other treatments for AML, such as Mylotarg (gemtuzumab ozogamicin), which targets CD33-positive AML cells.

Regulatory Considerations::

The FDA's request for additional trials underscores the rigorous standards for drug approval, ensuring that new treatments demonstrate both efficacy and safety before being approved for patient use.