FDA Approves 177Lu-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer


Lutetium-177-PSMA-617 is now FDA-approved for the treatment of patients with metastatic castration-resistant prostate cancer who have already received androgen receptor pathway inhibition and taxane-based chemotherapy.

The FDA has approved lutetium-177 (177Lu)-PSMA-617 (Pluvicto) to treat patients with metastatic castration-resistant prostate cancer (mCRPC) following androgen receptor pathway inhibition and taxane-based chemotherapy.1

Findings from the phase 3 VISION trial (NCT03511664) supported the regulatory decision; results from the study showed that patients with progressive prostate-specific membrane antigen (PSMA)–positive mCRPC experienced improved overall survival (OS) and radiographic progression-free survival (PFS) over SOC alone after receiving the targeted radioligand therapy in addition to standard of care (SOC). 2

Median overall survival (OS) with the experimental agent (n = 551) was deemed to be 15.3 months (95% CI, 14.2-16.9) at a 20.9-month follow-up, compared with an 11.3-month (95% CI, 9.8 -13.5) median OS with SOC alone (n = 280; HR, 0.62; 95% CI, 0.52-0.74; < .001). Median radiographic PFS was 8.7 months vs 3.4 months in the experimental and control cohorts, respectively (HR, 0.40; 99.2% CI, 0.29-0.57; < .001).

“The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” said Oliver Sartor, MD, Medical Director at Tulane Cancer Center, in a news release.3 “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”

The trial randomized patients 2:1 to receive either 177Lu-PSMA-617 plus best SOC (n=551) or best SOC alone (n=280). To be eligible for enrollment, all patients needed to have previously received a GnRH analog or had prior bilateral orchiectomy. In addition, patients needed to have received at least 1 AR pathway inhibitor or have received 1-2 lines of prior taxane-based chemotherapy regimens.

Overall, one third of patients with evaluable disease at baseline experienced an overall response with 177Lu-PSMA-617 compared to those who received SOC alone. Of note, the most common adverse events (AEs) associated with 177Lu-PSMA-617 treatment included fatigue (43%), dry mouth (39%), nausea (35%), anemia (low red blood cell counts) (32%), decreased appetite (21%), and constipation (20%).3

Common laboratory abnormalities associated with 177Lu-PSMA-617 included decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. These AEs occurred in more than 30% of patients receiving 177Lu-PSMA-617.

It is important to note that this treatment may yield additional risks from radiation exposure, myelosuppression, and renal toxicity, although the current safety follow-up available from the VISION trial is not sufficient yet to determine the late radiation-associated toxicities.

“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients,” said Jamie Bearse, CEO and President at ZERO – The End of Prostate Cancer. “The approval of Pluvicto offers new hope to the mCRPC community.”

The recommended administration for 177Lu-PSMA-617 is 7.4 GBq (200 mCi) delivered intravenously every 6 weeks for up to 6 doses, or until disease progression or unacceptable toxicity occurs.


  1. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. FDA. News release. March 23, 2022. Accessed March 24, 2022. https://bit.ly/3qyl0AV
  2. Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer. News release. Novartis. News release. March 23, 2022. Accessed March 24, 2022. https://bit.ly/36kz8Hp
  3. J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322

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