Biologics

Another Study Needed for Iomab-B BLA: FDA

FDA has asked Actinium Pharmaceuticals for another Phase 3 study to support a BLA submission for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia. “The FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing,” the company says. “The FDA has advised Actinium to conduct a study to evaluate allogeneic bone marrow transplant (BMT) using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation (Flu/TBI) versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI…” it says.

The study request follows interactions with the agency about Actinium’s clinical and chemistry, manufacturing and controls and discussions about its BLA pathway for the therapy, according to the company. It says the request was made despite its SIERRA Phase 3 trial meeting the primary endpoint of durable complete remission with statistical significance (p-value<0.0001) and other positive secondary endpoints including event-free survival.

“The SIERRA trial was conducted in accordance with guidance from the End of Phase 2 meeting with the FDA, which stated that positive results for dCR as the primary endpoint would be an acceptable endpoint to support an Iomab-B BLA filing,” Actinium says. “SIERRA did not meet the secondary endpoint of overall survival on an intent to treat basis analysis due to the high crossover rate with nearly 60% of control arm patients receiving Iomab-B followed by a BMT. Over the last several years, a majority of therapies for patients with AML have been approved based on achieving a positive overall survival endpoint.”

Actinium says it intends to further discuss with FDA the specifics of the additional clinical trial including the patient population. “Upon conclusion of its interactions with the FDA, Actinium will seek a strategic partner for Iomab-B for the U.S.,” it says.

Iomab-B is described as an induction and conditioning targeted radiotherapy agent comprising an anti-CD45 monoclonal antibody and an Iodine-131 radioisotope payload.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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