FDA says Actinium’s BLA for Iomab-B needs added info

Actinium Pharmaceuticals’ (NYSE: ATNM) shares closed down 60% yesterday and fell a further 10% to $2.23 in after-hours trading, when the company announced a regulatory setback for its Iead candidate.

Actinium revealed that it has now concluded both its clinical and Chemistry, Manufacturing and Controls (CMC) interactions with the US Food and Drug Administration (FDA) regarding the planned Biologics License Application (BLA) pathway for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia (r/r AML).

However, despite the SIERRA trial meeting the primary endpoint of durable Complete Remission (dCR) with statistical significance (p-value<0.0001) and other positive secondary endpoints including Event Free Survival (EFS) and safety, the FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing.