Novartis’ Pluvicto Gets FDA Approval for Advanced Prostate Cancer

The FDA has approved Novartis’ Pluvicto for the treatment of an advanced form of prostate cancer in patients who have previously received chemotherapy.

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapy that combines a targeting compound with a therapeutic radioisotope. The approved indication is for the treatment of prostate-specific, membrane antigen-positive metastatic castration-resistant prostate cancer in patients who have previously received androgen-receptor pathway inhibition and taxane-based chemotherapy.

The approval was based on the results of a phase 3 clinical trial in 831 participants in which Pluvicto combined with standard of care reduced deaths by 38 percent compared with standard of care alone.

Pluvicto is a registered product of Advanced Accelerator Applications, a Novartis subsidiary that specializes in radioligands and targeted radioligand therapies.