Novartis AG Sponsored ADR pharmaceutical (NVS.US) has received approval for a new indication of its blockbuster nuclear drug in China.
This is the third approved indication for this drug in China, and it is currently available for patients with PSMA+ metastatic prostate cancer at all stages.
On August 25, Novartis AG Sponsored ADR (NVS.US) announced that lutetium[177Lu] vipivotide tetraxetan (Chinese trade name: Paiweituo) has been approved in China for a new indication, to be used in combination with androgen receptor pathway inhibitors (ARPI) for the treatment of prostate-specific membrane antigen-positive (PSMA+) metastatic hormone-sensitive prostate cancer (mHSPC) patients. This marks the third indication for the drug approved in the country, and it is currently available for PSMA+ metastatic prostate cancer patients at all stagesfrom mHSPC to metastatic castration-resistant prostate cancer (mCRPC), covering multiple key treatment phases from before to after chemotherapy. Additionally, Novartis AG Sponsored ADR recently submitted a local production application for the drug in the country.
Lutetium[177Lu] vipivotide tetraxetan (177Lu-PSMA-617) is a radioligand therapy (RLT) acquired by Novartis AG Sponsored ADR through its acquisition of Endocyte. It is formed by conjugating a small molecule compound that targets PSMA with the therapeutic radioactive nuclide lutetium-177. Once in the bloodstream, lutetium[177Lu] vipivotide tetraxetan binds to prostate cancer cells expressing PSMA, after which the radiation energy released from the radioactive nuclide damages the target cells and surrounding tumor cells, impairing their DNA replication ability and/or triggering tumor cell death. The characteristics of this drug give it the potential to replace systemic radiotherapy.
In November 2025, lutetium[177Lu] vipivotide tetraxetan was first approved by the National Medical Products Administration (NMPA) for marketing to treat (1) PSMA+ mCRPC patients who had disease progression after previous treatment with ARPI and taxane chemotherapy; (2) PSMA+ mCRPC patients who had received ARPI treatment and were considered suitable for delaying chemotherapy.
In the global phase III PSMAddition study, PSMA+ mHSPC patients treated with lutetium[177Lu] vipivotide tetraxetan in combination with standard treatment regimens had a 33% lower risk of disease progression compared to the standard treatment group (HR=0.67) and a 20% lower risk of death compared to the control group (HR=0.80).
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