Novartis(US:NVS) Cai Jing Wang·2025-11-09 20:35Core Insights - Novartis announced the approval of its radioligand therapy (RLT) drug, Pluvicto® (Lutetium [177Lu] vipivotide tetraxetan injection), for two indications in China, targeting metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed after androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy [1][2] - This approval marks Pluvicto® as the first and only targeted PSMA radioligand therapy approved in China, providing new treatment options for advanced prostate cancer patients with limited choices [1] - The approvals are based on results from global Phase III VISION and PSMAfore studies, along with corresponding bridging studies conducted in China [1] Group 1 - Novartis is actively exploring the use of Lutetium [177Lu] vipivotide tetraxetan injection for earlier lines of prostate cancer treatment [2] - The Phase III PSMAddtion study in metastatic hormone-sensitive prostate cancer (mHSPC) has shown a significant 28% reduction in the risk of radiographic progression or death (HR 0.72, p=0.002) [2] - Based on these results, Novartis has submitted a new drug application to Chinese regulatory authorities for this indication, aiming to benefit a broader range of prostate cancer patients in China [2]