Bexlutry (lutetium Lu 177 dotatate injection) / Curium - LARVOL DELTA

Curium announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for BEXLUTRY lutetium Lu 177 dotatate injection for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults (GlobeNewswire) - "BEXLUTRY is a radioligand equivalent approved through the FDA’s 505(b)(2) pathway targeting LUTATHERA (lutetium Lu 177 dotatate), supported by published evidence and targeted bridging data that demonstrated a similar biological and chemical profile to a previously approved radiopharmaceutical therapy."

FDA approval • Gastrointestinal Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Curium Completes the Acquisition of Monrol as Part of its Plan to Significantly Expand Lutetium-177 Capacity and PET Footprint (GlobeNewswire) - "Curium Pharma...is pleased to announce the completion of its acquisition of Eczacıbaşı-Monrol Nuclear Products Co. (Monrol), a leading nuclear medicine player, which is headquartered in Istanbul, Turkey. The acquisition enhances Curium’s manufacturing capacity of Lutetium-177 (Lu-177) to meet the growing demand for isotope around the world and secure the supply for the future launch of Curium’s Lu-177 drug candidates, for Prostate Cancer (currently in development) and Neuroendocrine Tumours (pending approval)."

M&A • Neuroendocrine Tumor • Prostate Cancer

Curium Announces the Official Opening its New Netherlands Facility for the Production of Lutetium-177 – a Game Changer Therapy Isotope for Cancer Patients Worldwide (GlobeNewswire) - "Curium...announced today that it has officially opened an additional and new facility in Petten, Netherlands to produce non-carrier added lutetium-177 (Lu-177) to meet the growing global demand for Lu-177 for the treatment of cancer patients...Using in-licensed technology from Turkey-based Eczacıbaşı-Monrol, the facility will initially include two production lines (with ability to scale via further lines as needed in the future) to supply Curium’s proprietary Lu-177 product pipeline, as well as external pharmaceutical and hospital customers....'Curium’s new facility will add 52 weeks of fully-redundant capacity, ensuring security of supply for patients. With more than 100 active clinical trials around the world using Lu-177 across more than 20 indications, the new facility will have a life-saving impact on numerous patients in their fight against cancer for many years to come.'"

Commercial • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Curium Submits New Drug Application for Lutetium Lu 177 Dotatate Injection (GlobeNewswire) - "Curium...announced today that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection, which, if approved by the U.S. Food and Drug Administration (FDA), would be intended for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS)...Curium will work closely with the FDA through the review and approval process. Curium looks forward to potential approval of its Lutetium Lu 177 Dotatate formulation so that more patients suffering from GEP-NETS may have access to the potential benefits of radioligand therapy....Curium will provide further updates as it proceeds with its application through the FDA’s review process."

FDA filing • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor