Novartis Therapy Gets FDA Approval For Advanced Prostate Cancer

(RTTNews) - Novartis (NVS) said that the US Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer or PSMA-positive mCRPC that has spread to other parts of the body.

The patients have already been treated with other anticancer treatments--androgen receptor pathway inhibition and taxane-based chemotherapy.

The FDA approval was based on pivotal Phase III VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of overall survival and radiographic progression free survival were met.

Metastatic prostate cancer has a 5-year survival rate of less than 30%3; mCRPC patients who progress on multiple lines of therapy have limited treatment options.

Pluvicto is the first FDA-approved targeted radioligand therapy for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope. Pluvicto is expected to be available to physicians and patients within weeks.