Novartis AG Sponsored ADR pharmaceutical (NVS.US) first radioligand therapy drug Lutetium-PSMA-617 receives dual indications approval.

Novartis AG sponsored ADR pharmaceutical (NVS.US) announced that its radioligand therapy (RLT) drug Lutetia (Lutetia [177Lu] PSMA-617 injection) has received simultaneous approval for two indications by the National Medical Products Administration, including for the treatment of prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) in adults who have previously received androgen receptor pathway inhibitors (ARPI) and are suitable for delaying chemotherapy, and for PSMA-positive mCRPC adults who have previously received ARPI and taxane chemotherapy and have disease progression. As the first and currently only approved targeted PSMA radioligand therapy drug in China, the two indications for Lutetia were previously granted priority review designation and are now approved simultaneously, offering a new treatment option to more Chinese late-stage prostate cancer patients with limited treatment choices, with the potential to extend survival and improve quality of life.