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FDA Determines That Actinium Pharmaceuticals' Phase 3 Sierra Trial Is Not Adequate To Support A BLA Filing For Iomab-B For Relapsed Or Refractory Acute Myeloid Leukemia, Despite Its Statistically Significant Primary Endpoint

Author: Benzinga Newsdesk | August 05, 2024 07:12am
  • Additional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by FDA to support a BLA filing.
  • Actinium to request a meeting with the FDA to further discuss specifics of additional trial.
  • Actinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development efforts on Actimab-A, Iomab-ACT and preclinical programs

Posted In: ATNM


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