FDA has granted tentative approval for the Abbreviated New Drug Application for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of Lutathera (lutetium Lu 177 dotatate), which is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
FDA has approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
