Novartis AG (NVS.US) announced that its radioligand therapy (RLT) drug Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection) has received simultaneous approval from the National Medical Products Administration for two indications. The approved indications include treatment for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior androgen receptor pathway inhibitor (ARPI) therapy and are suitable for deferred chemotherapy, as well as adult patients with PSMA-positive mCRPC who have progressed after prior ARPI and taxane-based chemotherapy.

As the first and currently only approved PSMA-targeted radioligand therapy drug in China, Pluvicto® had previously been granted priority review status for both indications. The simultaneous approval is expected to provide a novel treatment option for more Chinese patients with advanced prostate cancer who have limited therapeutic choices, potentially extending survival and improving quality of life.