LNTH News & Events

Lantheus announced that the FDA has extended its review of the new drug application for LNTH-2501 by three months to June 29. The extension and revised target Prescription Drug User Free Act, or PDUFA, goal date of June 29 will allow the FDA additional time to review and consider further manufacturing related information submitted by Lantheus. This standard review extension is not related to the efficacy or safety data of LNTH-2501.

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.