LNTH News & Events

Lantheus announced that the FDA has approved Pylarify TruVu injection, a new formulation of its F 18 prostate-specific membrane antigen imaging agent. Pylarify TruVu is indicated for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen level. Pylarify TruVu is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis.

Lantheus Holdings announced that it has received U.S. Food and Drug Administration, FDA, tentative approval for the Abbreviated New Drug Application, ANDA, for Lutetium Lu 177 Dotatate, a radioequivalent version of Lutathera. Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.