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

Core Viewpoint - Novartis Pharmaceuticals (NVS.US) announced the simultaneous approval of its radioligand therapy (RLT) drug, Pluvicto (lutetium [177Lu] vipivotide tetraxetan injection), for two indications by the National Medical Products Administration (NMPA) in China, aimed at treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously progressed on androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy [1] Group 1 - The two approved indications are for adult patients with PSMA-positive mCRPC who have previously progressed after ARPI treatment and are suitable for delayed chemotherapy [1] - The drug is the first and currently the only approved targeted PSMA radioligand therapy in China, providing a new treatment option for advanced prostate cancer patients with limited treatment choices [1] - Both indications had previously received priority review designation, indicating the significance of this approval for patient care [1]