WASHINGTON (dpa-AFX) - Actinium Pharmaceuticals, Inc. (ATNM) announced Tuesday that it has received positive Scientific Advice from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA related to the EU approval pathway for Iomab-B.
In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application.
In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies. The EMA requested supporting data and information that is already being collected as part of the U.S. pivotal Phase 3 SIERRA trial.
The SIERRA trial is a 150 patient, randomized controlled study of Iomab-B that is currently enrolling patients in the U.S. Upon approval, Iomab-B is intended to be an induction and conditioning agent prior to a bone marrow transplant, often referred to as a hematopoietic stem cell transplant with an initial indication in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above.
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