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

Based on data from the phase 3 VISION trial, 177Lu-PSMA-617 may now be used to treat patients who were previously treated with androgen receptor pathway inhibitors plus taxane-based chemotherapy for metastatic prostate specific membrane antigen–positive castration-resistant prostate cancer.

The FDA granted approval to the targeted radioligand 177Lu-PSMA-617 (Pluctivo) for the treatment of patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with an androgen-receptor pathway inhibitor and taxane-based chemotherapy, according to drug developer Novartis.1

Data supporting the approval are from the phase 3 VISION study (NCT03511664), in which 177Lu-PSMA-617 plus standard-of-care (SOC) led to a statistically significant boost in imaging-based progression-free survival (PFS) vs SOC alone (HR, 0.40; 99.2% CI, 0.29-0.57; P < .001).

“With our unique strategy to tackle cancer by leveraging four therapeutic platforms, I am thrilled that with Pluvicto, we are bringing the targeted RLT platform to bear for treating eligible patients with mCRPC,” Susanne Schaffert, PhD, president of Novartis Oncology, said in a press release. “Today’s approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients.”

Data from the trial that were previously reported at the 2021 American Society of Clinical Oncology Annual Meeting showed a median PFS of 8.7 months in the 177Lu-PSMA-617 arm vs 3.4 months with SOC alone. Similarly, median overall survival was longer with the experimental regimen at 5.3 months vs 11.3 months, respectively (HR, 0.62; 95% CI, 0.52-0.74; P <.001).2

Treatment-emergent adverse effects of grade 3 or greater in severity occurred in 52.7% of patients receiving 177Lu-PSMA-617 compared with 38% of patients treated on SOC alone. The most common grade 3 or greater AEs reported in either arm were bone marrow suppression (23.4% vs 6.8%, respectively), fatigue (7% vs 2.4%), kidney effects (3.4% vs 2.9%), and nausea/vomiting (1.5% vs 0.5%).

Previously, 177Lu-PSMA-617 had been granted both a breakthrough therapy designation and a priority review designation in June and October 2021, respectively. The target Prescription Drug User Fee Act (PDUFA) date was set for the first half of 2022.

“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,” Jamie Bearse, CEO and President at ZERO – The End of Prostate Cancer, said in a statement. “The approval of Pluvicto offers new hope to the mCRPC community.”


  1. Novartis Pluvicto approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer. News release. Novartis. March 23, 2022. Accessed March 23, 2022. https://bit.ly/36lu4Ct
  2. Morris MJ, De Bono JS, Chi KN, et al. Phase 3 study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). J Clin Oncol. 2021;39(suppl 15):LBA4. doi:10.1200/JCO.2021.39.15_suppl.LBA4
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