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Important Safety Information

Risk From Radiation Exposure
PLUVICTO contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk for cancer.

Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with PLUVICTO consistent with institutional practices, patient treatment procedures, Nuclear...


PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy...

1. Hofman MS, Violet J, Hicks RJ, et al. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet Oncol. 2018;19(6):825-833. doi:10.1016/S1470-2045(18)30198-0 2. Abida W, Patnaik A, Campbell D, et al; TRITON2 Investigators. Rucaparib in men with metastatic castration-resistant prostate cancer harboring a BRCA1 or BRCA2 gene alteration. J Clin Oncol. 2020;38(32):3763-3772. doi:10.1200/JCO.20.01035 3. Yadav MP, Ballal S, Sahoo RK, et al. Radioligand therapy with 177Lu-PSMA for metastatic castration-resistant prostate cancer: a systematic review and meta-analysis. Am J Roentgenol. 2019;213(2):275-285. doi:10.2214/AJR.18.20845 4. Li L, Chang W, Yang G, et al. Targeting poly (ADP-ribose) polymerase and the c-Myb-TopBP1-ATR-Chk1 signaling pathway in castration-resistant prostate cancer. Sci Signal. 2015;7(326):ra47. doi:10.1126/scisignal.2005070 5. Violet J, Sandhu S, Iravani A, et al. Long-term follow-up and outcomes of retreatment in an expanded 50-patient single-center phase II prospective trial of 177Lu-PSMA-617 theranostics in metastatic castration-resistant prostate cancer. J Nucl Med. 2020;61(6):857-865. doi:10.2967/jnumed.119.236414 6. Barber TW, Singh A, Kulkarni HR, Niepsch K, Billah B, Baum RP. Clinical outcomes of 177Lu-PSMA radioligand therapy in earlier and later phases of metastatic castration-resistant prostate cancer grouped by previous taxane chemotherapy. J Nucl Med. 2019;60(7):955-962. doi:10.2967/jnumed.118.216820 7. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. Published online June 23, 2021. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322. 8. de Bono J, Mateo J, Fizazi K, et al. Olaparib for metastatic castration-resistant prostate cancer. N Engl J Med. 2020;382(22):2091-2102. doi:10.1056/NEJMoa1911440 9. Baum RP, Kulkarni HR, Schuchardt C, et al. 177Lu-labeled prostate-specific membrane antigen radioligand therapy of metastatic castration-resistant prostate cancer: safety and efficacy. J Nucl Med. 2016;57(7):1006-1013. doi:10.2967/jnumed.115.168443 10. Current K, Meyer C, Magyar CE, et al. Investigating PSMA-targeted radioligand therapy efficacy as a function of cellular PSMA levels and intratumoral PSMA heterogeneity. Clin Cancer Res. 2020;26(12):2946-2955. doi:10.1158/1078-0432.CCR-19-1485 11. Benešová M, Schäfer M, Bauder-Wüst U, et al. Preclinical evaluation of a tailor-made DOTA-conjugated PSMA inhibitor with optimized linker moiety for imaging and endoradiotherapy of prostate cancer. J Nucl Med. 2015;56(6):914-920. doi:10.2967/jnumed.114.147413 12. Maffey-Steffan J, Scarpa L, Svirydenka A, et al. The 68Ga/177Lu-theragnostic concept in PSMA-targeting of metastatic castration–resistant prostate cancer: impact of post-therapeutic whole-body scintigraphy in the follow-up. Eur J Nucl Med Mol Imaging. 2020;47(3):695-712. doi:10.1007/s00259-019-04583-2 13. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623. doi:10.3389/fonc.2018.00623 14. Pomykala KL, Czernin J, Grogan TR, Armstrong WR, Williams J, Calais J. Total-body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. J Nucl Med. 2020;61(3):405-411. doi:10.2967/jnumed.119.230318 15. Hope TA, Aggarwal R, Chee B, et al. Impact of 68Ga-PSMA-11 PET on management in patients with biochemically recurrent prostate cancer. J Nucl Med. 2017;58(12):1956-1961. doi:10.2967/jnumed.117.192476 16. Tsourlakis MC, Klein F, Kluth M, et al. PSMA expression is highly homogenous in primary prostate cancer. Appl Immunohistochem Mol Morphol. 2015;23(6):449-455. doi:10.1097/PAI.0000000000000110 17. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is associated with early PSA recurrence in surgically treated prostate cancer. Prostate. 2011;71(3):281-288. doi:10.1002/pros.21241 18. Pluvicto. Prescribing Information. Advanced Accelerator Applications USA, Inc. 19. Vlachostergios PJ, Niaz MJ, Sun M, et al. Prostate-specific membrane antigen uptake and survival in metastatic castration-resistant prostate cancer. Front Oncol. 2021;11:630589. doi:10.3389/fonc.2021.630589 20. Woythal N, Arsenic R, Kempkensteffen C, et al. Immunohistochemical validation of PSMA expression measured by 68Ga-PSMA PET/CT in primary prostate cancer. J Nucl Med. 2018;59(2):238-243. doi:10.2967/jnumed.117.195172 21. Sartor O, de Bono J, Chi KN, et al; VISION Investigators. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12)(suppl):1091-1103. doi:10.1056/NEJMoa2107322