Novartis has received National Medical Products Administration (NMPA) approval in China for two metastatic castration-resistant prostate cancer (mCRPC) indications for radioligand therapy Lutathera (lutetium Lu-177 dotatate) targeting PSMA-positive disease progression following androgen receptor pathway inhibitor therapy with or without prior taxane chemotherapy. The approvals mark the first for a PSMA-targeting radioligand therapy in China, and are based on the Phase III VISION trial showing 38% overall survival (OS) improvement, as well as the Phase III PSMAfore study demonstrating 6-month progression-free survival (PFS) advantage over alternative androgen receptor pathway inhibitor (ARPI) switching.

Prostate cancer represents the second most common male malignancy in China, with 54% of patients presenting metastatic disease at diagnosis and a 36.6% 5-year survival rate for the castration-resistant stage. Lutathera's mechanism combines a lutetium-177 isotope with a PSMA-binding peptide, enabling targeted radiation delivery to metastatic lesions while minimising healthy tissue exposure through short particle penetration range. Novartis plans to expand its radioligand therapy portfolio into neuroendocrine tumours, breast cancer and gastrointestinal malignancies through novel isotopes and targeting ligands.

According to PharmCube's NextBiopharm® database, Lutathera is under development in China for five other oncololgy indications. Click here to request a free trial for NextBiopharm®.