Novartis’ Pluvicto receives approval in China for a new indication

CAR-T Digest - August 2020

26 August 2026: Novartis’ Pluvicto receives approval in China for a new indication

Novartis announced that China’s NMPA approved a new indication for Pluvicto in combination with an androgen receptor pathway inhibitor for adults with PSMA-positive mHSPC, marking its third indication in China and expanding its use from the previously approved mCRPC setting into earlier-line mHSPC
The approval is based on the global phase 3 PSMAddition study, where patients with PSMA-positive mHSPC treated with Pluvicto plus standard of care (ARPI + ADT) achieved a 33% reduction in the risk of disease progression or death versus standard of care alone (HR=0.67) and a 20% reduction in the risk of death (HR=0.80)
The approval addresses a significant unmet need in PSMA-positive mHSPC, where disease progression remains a major challenge despite androgen-directed therapy, supporting earlier use of targeted radioligand therapy to delay progression to metastatic castration-resistant prostate cancer
Pluvicto is a PSMA-targeted radioligand therapy that delivers the beta-emitting radioisotope lutetium-177 directly to PSMA-expressing prostate cancer cells, enabling targeted radiation-induced tumor cell damage
Strategically, the China approval expands Pluvicto into the hormone-sensitive setting and strengthens its position across the metastatic prostate cancer treatment continuum, while further broadening Novartis’ radioligand therapy footprint in China