By Fineline Cube 
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received expanded indication approval from the US Food and Drug Administration (FDA) for its radioligand therapy (RLT) Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The PSMA-targeted therapy is now approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have been treated with an androgen receptor pathway inhibitor (ARPI) and are candidates for delayed chemotherapy.
Expanded Indication
Pluvicto, the first FDA-approved RLT for castration-resistant prostate cancer, was initially approved in 2022 for PSMA-positive mCRPC patients previously treated with androgen deprivation therapy and chemotherapy. The new approval triples the therapy’s applicable population by allowing patients suitable for delayed chemotherapy to receive Pluvicto first.
Clinical Trial Results
The approval is based on positive results from the PSMAfore trial, which involved 469 PSMA-positive mCRPC patients. The study demonstrated that Pluvicto reduced the risk of imaging progression or death by 59% and significantly improved median radiographic progression-free survival (rPFS) to 11.6 months compared to 5.6 months in the control group.-Fineline Info & Tech