WEB: Actinium to Submit Biologics License Application
BLA Seeking Approval for Iomab-B
Company to Address Patients Age 55 with Relapsed or Refractory AML
Actinium Pharmaceuticals, Inc. (NASDAQ: ATNM) is pleased to announce its intent to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2023 seeking approval for Iomab-B.
Iomab-B is a targeted alpha therapy (TAT) being developed for the treatment of relapsed or refractory acute myeloid leukemia (AML) in patients age 55 or older.
The BLA submission will be based on data from the Phase 3 Iomab-B AML-01 Study, which evaluated the efficacy and safety of Iomab-B in patients with relapsed or refractory AML. The study met its primary endpoint of improved overall survival (OS) and also demonstrated a favorable safety profile.
The data from the Iomab-B AML-01 Study support Actinium's belief that Iomab-B has the potential to be a valuable new treatment option for patients with relapsed or refractory AML, a difficult-to-treat cancer with few effective therapies.
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