drugset

Drugs / [177Lu]Lu-PSMA-617

Follow last change Aug 2026 re-read 3 minutes ago

[177Lu]Lu-PSMA-617

also known as 177Lu-PSMA-617 · Pluvicto

Other / unclassified

Developed for: castration-resistant prostate carcinoma · prostate cancer · prostate carcinoma · prostate neuroendocrine neoplasm
Investigated by: Novartis Pharmaceuticals · Advanced Accelerator Applications · Bristol-Myers Squibb · Hospices Civils de Lyon · University Hospital, Essen

Trials 5

today NCT06388369 · Ph 1/2 NCT06866938 · Ph 2 NCT06379217 · Ph 1 NCT05670106 · Ph 2 NCT05658003 · Ph 2

2024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT06379217	Jul 2024 → Aug 2026 overdue	prostate neuroendocrine neoplasm	Novartis Pharmaceuticals	Active not recruiting	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT06388369	Aug 2025 → Mar 2026	prostate cancer	University Hospital, Essen	Terminated	No outcome recorded Stop: Enrollment
Phase 23 trials
Phase 2	NCT06866938	Apr 2025 → Apr 2027 expected	castration-resistant prostate carcinoma	Hospices Civils de Lyon	Recruiting	No outcome recorded
Phase 2	NCT05670106	May 2023 → May 2024	castration-resistant prostate carcinoma	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT05658003	May 2023 → Dec 2024 overdue	prostate carcinoma	Novartis Pharmaceuticals	Active not recruiting	No outcome recorded

Press releases naming this drug 18 releases

Date	Issuer	Release
2026-07-31	Novartis Pharmaceuticals	FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease novartis.com ↗
2026-05-31	Novartis Pharmaceuticals	Pluvicto™ demonstrated consistent efficacy across key patient subgroups in metastatic hormone-sensitive prostate cancer novartis.com ↗
2026-05-17	Novartis Pharmaceuticals	New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic hormone-sensitive prostate cancer novartis.com ↗
2026-02-24	Novartis Pharmaceuticals	New real‑world data reinforce earlier use of Pluvicto™ before chemotherapy in metastatic castration-resistant prostate cancer novartis.com ↗
2025-10-19	Novartis Pharmaceuticals	PSMAddition data show Novartis Pluvicto™ delays progression to end-stage prostate cancer novartis.com ↗
2025-06-02	Novartis Pharmaceuticals	Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer novartis.com ↗
2025-03-28	Novartis Pharmaceuticals	FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer novartis.com ↗
2024-01-05	Novartis Pharmaceuticals	Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis novartis.com ↗
2023-10-26	Novartis Pharmaceuticals	Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers novartis.com ↗
2023-10-23	Novartis Pharmaceuticals	Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting novartis.com ↗
2022-12-13	Novartis Pharmaceuticals	Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer novartis.com ↗
2022-12-05	Novartis Pharmaceuticals	Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer novartis.com ↗
2022-10-14	Novartis Pharmaceuticals	Novartis receives positive CHMP opinion for Pluvicto® for patients with progressive, PSMA-positive metastatic castration-resistant prostate cancer novartis.com ↗
2022-03-23	Novartis Pharmaceuticals	Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer novartis.com ↗
2021-09-17	Novartis Pharmaceuticals	Novartis reports positive health-related quality of life data for 177Lu-PSMA-617 radioligand therapy in patients with advanced prostate cancer at ESMO 2021 novartis.com ↗
2021-06-24	Novartis Pharmaceuticals	Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine novartis.com ↗
2021-06-03	Novartis Pharmaceuticals	Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study novartis.com ↗
2021-03-23	Novartis Pharmaceuticals	Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer novartis.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

Field	Value	Cited text
Known as	[177Lu]Lu-PSMA-617	“2 cycles of 7,4 GBq \[177Lu\]Lu-PSMA-617 at 6 weeks intervals” NCT06388369 ↗ 4 NCT06866938 ↗ NCT06379217 ↗ NCT05658003 ↗ NCT05670106 ↗
Known as	177Lu-PSMA-617	“BACKGROUND: 177Lu-PSMA-617 is a radioligand therapy targeting cells expressing prostate-specific membrane antigen (PSMA).” PMID 41764712 ↗ Mar 2026
Known as	Pluvicto	“[177Lu]Lu-PSMA-617 (Pluvicto, Novartis)” NCT06866938 ↗
Modality	Other / unclassified	“targeted radioligand therapy (RLT)” NCT06379217 ↗
Route	Intravenous	“administered intravenously once every 6 weeks (1 cycle) for 6 cycles” NCT05658003 ↗