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Curium's Lutetium-177 Injection Approved by FDA for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Radiopharmaceutical company Curium recently announced that its developed lutetium-177 (Lu-177) dotatate injection (trade name: Bexlutry) has received formal approval from the U.S. Food and Drug Administration (FDA). The drug is indicated for the treatment of somatostatin receptor-positive adult gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The specific indication scope includes various neuroendocrine tumors occurring in the adult foregut, midgut, and hindgut. Bexlutry is an advanced radioligand therapy whose mechanism of action lies in its ability to specifically bind to somatostatin receptors highly expressed on the surface of such tumors. Through this precise binding, the drug can deliver...

2026-09-16

Prostate cancer becomes most common cancer among men in South Korea, Lu-177 PSMA therapy reaches cumulative 200 procedures

Prostate cancer incidence in South Korea has continued to rise, making it the most common cancer among men in the country. Meanwhile, a novel nuclear medicine treatment for metastatic prostate cancer—Lutetium-177 (Lu-177) prostate-specific membrane antigen (PSMA) radioligand therapy—is accumulating more clinical cases. Seoul St. Mary's Hospital Uro-Oncology Center stated on September 1 that since performing South Korea's first Lu-177 PSMA treatment on November 2, 2020, the center had administered a cumulative total of 200 such treatments to 84 patients with metastatic prostate cancer as of the 21st of last month. Metastatic castration-resistant prostate cancer refers to a state in which prostate cancer continues to progress despite androgen suppression therapy. As the disease advances, patients have fewer treatment options and a worse prognosis, making it essential to select appropriate treatment modalities and sequencing based on prior treatment history and physical condition.

2026-09-02

Novartis Files Localized Production Application in China for Lutetium [177Lu] Vipivotide Tetraxetan

On August 24, information on the website of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration showed that Novartis' nuclear medicine product Lutetium [177Lu] Vipivotide Tetraxetan had a localized production application submitted in China. On the same day, two indications for the drug were proposed for priority review, and the relevant review matters may correspond to this localized production application. Lutetium [177Lu] Vipivotide Tetraxetan, namely 177Lu-PSMA-617, is a radioligand therapy (RLT) drug acquired by Novartis following its acquisition of Endocyte. The drug consists of a small-molecule compound targeting prostate-specific membrane antigen (PSMA) conjugated to the therapeutic radionuclide Lutetium-177. Upon entering the bloodstream, the drug binds to prostate cancer cells expressing PSMA, and...

2026-08-25

US FDA Approves Pluvicto Expanded Indication for Treatment of PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer

On July 31, 2026, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive prostate cancer. This disease is commonly referred to as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on results from the Phase III PSMAddition trial. The study showed that compared with standard of care alone, namely ARPI combined with androgen deprivation therapy (ADT), Pluvicto plus standard of care reduced the risk of disease progression or death by...

2026-08-03

TerraPower Isotopes to Donate Actinium-225 via Oncidium Foundation to Support Cancer Treatment Accessibility

TerraPower Isotopes (TPI), a subsidiary of U.S. nuclear innovation company TerraPower, announced on July 29 that it will coordinate the donation of the rare medical isotope actinium-225 (Ac-225) through the Oncidium Foundation to support economically disadvantaged cancer patients in accessing targeted radionuclide therapy. The Oncidium Foundation is a non-profit organization dedicated to promoting global access to targeted radionuclide cancer treatments. Its RLT-Connect program aims to help financially challenged patients access relevant therapies, reducing treatment disparities caused by geographic and economic conditions. This donation also marks TPI's entry into Oncidium's collaborative ecosystem of radioisotope suppliers, medical practitioners...

2026-07-30