FDA Approves New Prostate Cancer Treatment

A targeted radioligand therapy, Pluvicto (lutetium Lu 177 vipivotide tetraxetan), has been approved for use in adults with previously treated metastatic castration-resistant prostate cancer (mCRPC). All eligible patients must have been previously treated with taxane-based chemotherapy and androgen receptor pathway inhibition, and test positive for a prostate-specific membrane antigen (PSMA).

The efficacy of the treatment was evaluated in VISION, a randomized, open-label trial that compared best standard of care alone vs with lutetium Lu 177 vipivotide tetraxetan in 831 men with PSMA-positive mCRPC that was progressing. Patients were randomly assigned in a 2:1 ratio to receive either the best standard of care plus lutetium Lu 177 vipivotide tetraxetan, 7.4 GBq (200 mCi) every 6 weeks until as many as 6 doses were given, or to the best standard of care alone.

VISION showed a statistically significant improvement in overall survival (OS) with  lutetium Lu 177 vipivotide tetraxetan. For OS, the hazard ratio (HR) for the treatment plus best standard of care compared with best standard of care alone was 0.62 (95% CI, 0.52 to 0.74; P < .001). In the treatment plus best standard of care arm, median OS was 15.3 months (95% CI, 14.2 to 16.9) vs 11.3 months (95% CI, 9.8 to 13.5) in the best standard of care alone arm.

The recommended dose of lutetium Lu 177 vipivotide tetraxetan is 7.4 GBq (200 mCi) given intravenously every 6 weeks until 6 doses have been given, the cancer progresses, or unacceptable toxicity results.

—Ellen Kurek

Reference:

U.S. Food and Drug Administration. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. News release. Updated March 23, 2022. Accessed April 21, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer