RadioMedix, and Orano Med, two clinical stage radiopharmaceutical companies, have just announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who are naïve to peptide receptor radionuclide therapy (PRRT). AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. Due to their high energy and short path length, alpha emitters enable specific targeting and killing of individual cancer cells, while minimizing toxicity to surrounding healthy tissue. AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.

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RadioMedix and Orano Med receive FDA Breakthrough Therapy Designation for AlphaMedixTM in Gastroenteropancreatic Neuroendocrine Tumors

Source: ORANO