Core Viewpoint - Novartis Pharmaceuticals (NVS.US) announced that its radioligand therapy (RLT) drug, Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection), received approval from the National Medical Products Administration for two indications related to metastatic castration-resistant prostate cancer (mCRPC) in adult patients [1] Group 1: Drug Approval Details - Pluvicto® is the first and currently the only targeted PSMA radioligand therapy drug approved in China [1] - The two approved indications are for adult patients with PSMA-positive mCRPC who have previously progressed after androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy, and for those who have progressed after ARPI and taxane chemotherapy [1] - Both indications had previously received priority review designation, indicating their significance in addressing unmet medical needs [1] Group 2: Market Implications - The approval is expected to provide a new treatment option for Chinese patients with advanced prostate cancer who have limited treatment choices, potentially extending survival and improving quality of life [1]
诺华制药(NVS.US)首个放射配体疗法药物派威妥®双适应症同时获批