Drugs / 177Lu-PSMA-617
177Lu-PSMA-617
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 2 milestones | |||||
| Filed | US (FDA) | Pluvicto | castration-resistant prostate carcinoma | 2024-10-29 | “Completed FDA submission for Pluvicto pre-taxane mCRPC label expansion based on the positive Phase III PSMAfore study.” novartis.com ↗ |
| Filed | EU (EMA) | Pluvicto | castration-resistant prostate carcinoma | 2022-03-23 | “Novartis has submitted marketing authorization for Pluvicto to the European Medicines Agency” novartis.com ↗ |
| Filed progesterone-receptor positive breast cancer 1 milestone | |||||
| Filed | US (FDA) | Pluvicto | progesterone-receptor positive breast cancer | 2026-02-04 | “Pluvicto (lutetium Lu177 vipivotide tetraxetan) FDA submission for Pluvicto in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) was completed based on Phase III...” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | PLUVICTO | — | 2025-03-28 – 2026-07-31 | fda.gov ↗ |
| Approved | EU (EMA) | Pluvicto | — | 2022-12-09 | europa.eu ↗ |
| Approved | US (FDA) | PLUVICTO | — | 2022-03-23 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06516510 | Oct 2024 → Aug 2025 | metastatic prostate carcinoma | Blue Earth Therapeutics Ltd | Terminated | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT07682649 | Aug 2026 → Aug 2027 expected | castration-resistant prostate carcinoma | University of Michigan Rogel Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07145177 | Mar 2026 → Oct 2028 expected | metastatic prostate carcinoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1 | NCT07219147 | Mar 2026 → Jul 2028 expected | prostate adenocarcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07223034 | Oct 2025 → Oct 2027 expected | IDH-wildtype glioblastoma, diffuse astrocytoma, diffuse glioma, H3 G34 mutant, diffuse midline glioma, H3 K27-altered +1 | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07054346 | Jul 2025 → Apr 2027 expected | prostate carcinoma | Thomas Hope | Recruiting | No outcome recorded |
| Phase 1 | NCT06303713 | May 2024 → Oct 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05818683 | Apr 2023 → Aug 2027 expected | prostate carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT05162573 | Dec 2021 → Sep 2025 | prostate neoplasm | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT05079698 | Oct 2021 → Oct 2027 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04886986 | Jun 2021 → Dec 2027 expected | prostate cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT05682443 | Dec 2023 → Nov 2026 expected | prostate carcinoma | OncoC4, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05340374 | Jul 2022 → Jun 2026 overdue | castration-resistant prostate carcinoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04430192 | Aug 2020 → Dec 2022 overdue | prostate neoplasm | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03545165 | Apr 2018 → Jul 2020 | prostate cancer | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 1/2 | NCT03042468 | Dec 2016 → Sep 2021 | prostate cancer | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 223 trials · 2 met primary | ||||||
| Phase 2 | NCT07698535 | Dec 2026 → Jul 2029 expected | prostate adenocarcinoma | University of Washington | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07860554 | Nov 2026 → Dec 2027 expected | prostate adenocarcinoma | Emory University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07550517 | Aug 2026 → Aug 2032 expected | — | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT07650240 | Aug 2026 → Dec 2030 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06783348 | Apr 2026 → Jan 2028 expected | clear cell renal carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 2 | NCT07150715 | Dec 2025 → Oct 2030 expected | prostate adenocarcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07025512 | Aug 2025 → May 2026 | anemia, castration-resistant prostate carcinoma, thrombocytopenia | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT06964958 | Jul 2025 → Dec 2026 expected | clear cell renal carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06526299 | Apr 2025 → Dec 2027 expected | castration-resistant prostate carcinoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06632977 | Feb 2025 → Apr 2030 expected | castration-resistant prostate carcinoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT06449781 | Jan 2025 → Nov 2030 expected | prostate cancer | Maria Sklodowska-Curie National Research Institute of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT06216249 | Aug 2024 → Dec 2027 expected | prostate carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06288113 | Aug 2024 → Jan 2027 expected | castration-resistant prostate carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06200103 | May 2024 → Dec 2029 expected | castration-resistant prostate carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06199453 | Jan 2024 → Nov 2027 | adenoid cystic carcinoma | Maria Sklodowska-Curie National Research Institute of Oncology | Withdrawn | No outcome recorded |
| Phase 2 | NCT05766371 | Dec 2023 → May 2027 expected | prostate carcinoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT06084338 | Dec 2023 → Nov 2027 expected | prostate cancer | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT03454750 | Oct 2022 → May 2024 | castration-resistant prostate carcinoma | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Completed | No outcome recorded |
| Phase 2 | NCT05150236 | Apr 2022 → Aug 2024 | prostate cancer, urinary system neoplasm | Australian and New Zealand Urogenital and Prostate Cancer Trials Group | Unknown | No outcome recorded |
| Phase 2 | NCT04663997 | Aug 2021 → Aug 2025 overdue | prostate cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04443062 | Jul 2020 → Apr 2025 | prostate cancer | Radboud University Medical Center | Completed | Met primary |
| Phase 2 | NCT04343885 | Apr 2020 → Mar 2026 overdue | prostate carcinoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | Met primary |
| Phase 2 | NCT03042312 | Jul 2017 → Jan 2020 | castration-resistant prostate carcinoma | Endocyte | Terminated | No outcome recorded Stop: Enrollment |
| Phase 36 trials · 3 met primary | ||||||
| Phase 3 | NCT07200830 | Mar 2026 → Sep 2034 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06496581 | Sep 2024 → Feb 2033 expected | metastatic prostate carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT06320067 | Jun 2024 → Apr 2031 expected | metastatic prostate carcinoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT04689828 | Jun 2021 → Oct 2022 overdue | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT04720157 | Jun 2021 → Jan 2025 overdue | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT03511664 | May 2018 → Jan 2021 | prostate cancer | Endocyte | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07677566 | Jul 2026 → Jul 2027 expected | prostate cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04825652 | — | castration-resistant prostate carcinoma | Advanced Accelerator Applications | No longer available | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT06943495 Comparator | Aug 2025 → Mar 2029 expected | castration-resistant prostate carcinoma | Jean-Mathieu Beauregard | Recruiting | No outcome recorded |
| Phase 1 | NCT06095089 Background | Nov 2023 → Jun 2027 expected | prostate neoplasm | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT05613894 Background | Jul 2023 → Dec 2026 | prostate carcinoma | University of Utah | Suspended | No outcome recorded |
| Phase 1/2 | NCT07206056 Comparator | Oct 2025 → Nov 2029 expected | castration-resistant prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06329830 Background | Oct 2024 → Oct 2026 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Baptist Health South Florida | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06145633 Background | Sep 2024 → Dec 2026 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07852195 Comparator | Jan 2027 → Mar 2029 expected | prostate adenocarcinoma | ECOG-ACRIN Cancer Research Group | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 44
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Novartis Pharmaceuticals | Regulatory FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease novartis.com ↗
Novartis today announced the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer, commonly known as metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2026-05-31 | Novartis Pharmaceuticals | Results Pluvicto™ demonstrated consistent efficacy across key patient subgroups in metastatic hormone-sensitive prostate cancer novartis.com ↗
Pluvicto demonstrated a similar rPFS improvement across key subgroups, consistent with the previously reported primary endpoint showing a 28% reduction in the risk of radiographic progression or death (HR 0.72; 95% CI: 0.58, 0.90). |
| 2026-05-17 | Novartis Pharmaceuticals | Results New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic hormone-sensitive prostate cancer novartis.com ↗
Risk of PSA progression was 58% lower (HR 0.42; 95% CI: 0.30-0.59) in patients treated with Pluvicto plus SoC compared to SoC alone. |
| 2026-02-24 | Novartis Pharmaceuticals | Results New real‑world data reinforce earlier use of Pluvicto™ before chemotherapy in metastatic castration-resistant prostate cancer novartis.com ↗
Real-world use of Pluvicto resulted in a median progression-free survival (PFS) of 13.5 months (95% CI: 11.7 – 14.7 months) in men with metastatic castration-resistant prostate cancer (mCRPC) who had been treated with ≥1 androgen receptor pathway inhibitor (ARPI) and were taxane-naïve. |
| 2025-10-19 | Novartis Pharmaceuticals | Results PSMAddition data show Novartis Pluvicto™ delays progression to end-stage prostate cancer novartis.com ↗
Pluvicto delayed time to progression to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.70; 95% CI: 0.58, 0.84) 1 . |
| 2025-06-02 | Novartis Pharmaceuticals | Results Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer novartis.com ↗
At interim analysis, PSMAddition trial met its primary endpoint showing statistically significant and clinically meaningful benefit for Pluvicto™ plus hormone therapy versus hormone therapy alone, with positive trend in overall survival (OS) 1 |
| 2025-05-12 | BAMF Health | Regulatory Prostate Cancer Patients Now Have an Option Other Than Chemotherapy bamfhealth.com ↗
With this new indication, patients can now be considered for PSMA-targeted radiopharmaceutical therapy after treatment with ADT and ARPI. |
| 2025-03-28 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer novartis.com ↗ |
| 2024-04-23 | Novartis Pharmaceuticals | Results Novartis delivers double-digit sales growth and core margin expansion in Q1; FY 2024 guidance raised novartis.com ↗
Pluvicto Phase III PSMAfore updated OS results demonstrated HR<1.0 in pre-taxane mCRPC |
| 2024-02-28 | Radiopharm Theranostics, Ltd | Results Pilot Study Validates RAD Terbium-161 Radiotherapeutics radiopharmtheranostics.com ↗
The study demonstrated that 161Tb-PSMA-617 delivers markedly higher tumor-absorbed doses compared to 177Lu-PSMA-617, whereas the absorbed doses of the relevant organs at risk were only slightly higher. |
| 2024-01-05 | Novartis Pharmaceuticals | Regulatory Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis novartis.com ↗
Novartis announced today that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States. |
| 2023-10-26 | Novartis Pharmaceuticals | Regulatory Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers novartis.com ↗
Novartis today announced that the US Food and Drug Administration has classified the Pluvicto ® (lutetium Lu 177 vipivotide tetraxetan) drug shortage status as resolved. |
| 2023-10-23 | Novartis Pharmaceuticals | Results 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 ↗
Phase III PSMAfore trial with Pluvicto™ met its primary endpoint of radiographic progression-free survival (rPFS) with a HR of 0.41 1 ; Pluvicto more than doubled median rPFS to 12.0 months per updated analysis* |
| 2023-04-11 | Bayer | Results Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting bayer.com ↗
Radium-223 demonstrates increased antitumor activity in combination with 177Lu-PSMA-617 in the intratibial LNCaP xenograft model of bone metastatic prostate cancer |
| 2022-12-13 | Novartis Pharmaceuticals | Regulatory 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 ↗
Basel, December 13, 2022 — Novartis today announced the European Commission (EC) approved Pluvicto ® (INN: lutetium ( 177 Lu) vipivotide tetraxetan), a targeted radioligand therapy. |
| 2022-12-05 | Novartis Pharmaceuticals | Results 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 ↗
Today, Novartis announced the pivotal Phase III PSMAfore study with Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. |
| 2022-10-14 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Pluvicto® for patients with progressive, PSMA-positive metastatic castration-resistant prostate cancer novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto ® (INN: lutetium ( 177 Lu) vipivotide tetraxetan) (formerly referred to as 177 Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy. |
| 2022-08-30 | Novartis Pharmaceuticals | Results Novartis presents new data in breast and prostate cancer at ESMO novartis.com ↗
Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial |
| 2022-03-23 | Novartis Pharmaceuticals | Regulatory Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer novartis.com ↗ |
| 2021-11-12 | Eckert & Ziegler Radiopharma GmbH | Regulatory Eckert & Ziegler Announces Clinical Trial Notification for Joint Clinical Trial in Japan ezag.com ↗
Eckert & Ziegler (ISIN DE0005659700, TecDAX) announced that the Clinical Trial Notification (CTN) of a joint clinical study with Novartis Pharma K.K. (Japan) was accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for 68 Ga-PSMA-11, an investigational radioligand imaging agent and 177 Lu-PSMA-617, an investigational radioligand therapy in metastatic prostate cancer. |
| 2021-09-17 | Novartis Pharmaceuticals | Results 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 ↗
Novartis today announced positive health-related quality of life (HRQoL) data from its Phase III VISION study evaluating 177 Lu-PSMA-617, an investigational targeted radioligand therapy, plus standard of care for metastatic castration-resistant prostate cancer (mCRPC) versus standard of care alone. |
| 2021-08-30 | Novartis Pharmaceuticals | Results Novartis presents important overall survival and quality-of-life results across solid tumor portfolio, among other key data at ESMO novartis.com ↗
Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer |
| 2021-08-05 | Noxopharm Limited | Results Veyonda Survival Advantage in LuPSMA Therapy Confirmed noxopharm.com ↗
Important animal study shows that adding Veyonda to 177lutetium-PSMA-617 results in regression of prostate cancer |
| 2021-06-24 | Novartis Pharmaceuticals | Results Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine novartis.com ↗ |
| 2021-06-04 | Noxopharm Limited | Results Noxopharm Set to Benefit From Novartis ASCO Data noxopharm.com ↗
The Novartis VISION study reported a median Overall Survival (mOS) of 15.3 months for 177Lutetium-PSMA-617 + standard of care versus 11.3 months for standard of care alone |
| 2021-06-03 | Novartis Pharmaceuticals | Results 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 ↗ |
| 2021-05-31 | Noxopharm Limited | Results New Independent Trial Data Supports Potential of Veyonda noxopharm.com ↗
WARMTH study is first reported large-scale multi-national study of Novartis experimental drug, 177lutetium-PSMA-617, in late-stage prostate cancer and showed a median overall survival (mOS) of 11.6 months |
| 2021-03-23 | Novartis Pharmaceuticals | Results Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer novartis.com ↗
The trial met both primary endpoints of overall survival and radiographic progression-free survival 1 , helping to move closer the ambition of becoming the targeted treatment for >80% of patients with advanced prostate cancer. |
| 2021-03-05 | Noxopharm Limited | Results Noxopharm Presents to H.C. Wainwright Global Conference noxopharm.com ↗
Median Overall Survival: 19.7 monthsa remarkable result for this late stage of the disease |
| 2021-02-15 | Noxopharm Limited | Results LuPIN Survival Outcome Confirmed by Conference Presentation noxopharm.com ↗
Drug combination NOX66 (Veyonda) and 177lutetium-PSMA-617 delivers high response rates in heavily pre-treated men with end-stage prostate cancer |
| 2021-02-09 | Noxopharm Limited | Results Major Survival Benefit in Prostate Cancer Patients Announced noxopharm.com ↗
LuPIN drug combination of Veyonda and 177Lu-PSMA-617 (Novartis) results in half of all patients surviving at least 19.7 months, a ground-breaking outcome for men with end-stage (Stage 4) disease and no remaining treatment options |
| 2020-08-11 | Noxopharm Limited | Results Peer-Reviewed Publication Strengthens Case For Veyonda noxopharm.com ↗
Noxopharm Limited (ASX:NOX) is pleased to announce the publication of the first manuscript of the LuPIN trial in the journal, European Urology Oncology. |
| 2020-06-01 | Noxopharm Limited | Results ASCO 2020 Highlights NOX66 Potential in Late-Stage Cancer noxopharm.com ↗
Combination treatment (Veyonda + 177Lu-PSMA-617) was safe and well tolerated. |
| 2020-03-31 | Noxopharm Limited | Results Noxopharm Virtual Roadshow Corporate Presentation noxopharm.com ↗
In summary, combination therapy of Veyonda® and 177Lu-PSMA-617 showed major benefits to patients and underscores the Company’s confidence in Veyonda® eventually becoming a standard drug in the management of prostate cancer |
| 2020-02-27 | Noxopharm Limited | Results Noxopharm Corporate Presentation February 2020 noxopharm.com ↗
Median PFS quadrupled through the addition of Veyonda® (8.4 months vs 2.0 months with 177Lu-PSMA-617 alone) |
| 2020-02-14 | Noxopharm Limited | Results Pronounced survival benefit in LuPIN interim trial data noxopharm.com ↗
The data presented at ASCO GU today reports the interim results from the first 32 patients receiving the combination. |
| 2020-01-29 | Noxopharm Limited | Results Noxopharm Non-Deal Roadshow Presentation noxopharm.com ↗
In summary, combination therapy of Veyonda® and 177Lu-PSMA-617 shows benefits to patients well above that achieved with 177Lu-PSMA-617 therapy alone and underscores the Company’s confidence in Veyonda® eventually becoming a standard drug in the management of prostate cancer |
| 2019-11-12 | Noxopharm Limited | Results LuPIN Data Being Presented To Conference noxopharm.com ↗
Within the limits of comparing data sets from different studies, combination therapy was superior to monotherapy in terms of: |
| 2019-09-30 | Noxopharm Limited | Results Further Review Shows Major Clinical Benefits from Veyonda noxopharm.com ↗ |
| 2019-09-17 | Noxopharm Limited | Results Veyonda and Radiotherapy Profiled at Key Oncology Meeting noxopharm.com ↗ |
| 2019-09-16 | Noxopharm Limited | Results NOX EGM Chairman's Address and Presentation noxopharm.com ↗
The investigators recently combined the two sets of data to provide a comparison and this was accepted for presentation at a conference in mid-November 2019. |
| 2019-06-26 | Noxopharm Limited | Results Conference Hears of Positive Interim Data from LuPIN Trial noxopharm.com ↗
Overall 69% PSA response rate (>50% reduction in PSA levels) with 177Lu-PSMA-617 + Veyonda |
| 2019-05-20 | Noxopharm Limited | Results LuPIN Trial Demonstrates High Rates of Response noxopharm.com ↗
69% combined PSA response rate is higher than that observed in studies of 177Lu-PSMA-617 alone |
| 2018-04-17 | Noxopharm Limited | Results St Vincent's Hospital study passes first milestone noxopharm.com ↗
Promising clinical response in 3 of 4 patients on lowest NOX66 dosage. |
All press releases naming this drug 46 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 177Lu PSMA 617 | “PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when...” NCT06496581 ↗33“Five participants will receive a single dose of 177Lu-PSMA-617 radioligand therapy intravenously (IV), five participants will receive a single dose of 177Lu-PSMA-617...” NCT07054346 ↗ “(177)Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer...” PMID 39293462 ↗ Sep 2024 “177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body.” NCT04663997 ↗ “injection of 3.7-5.5 GBq of 177Lu-PSMA-617 repeated four times at interval of 8 weeks.” PMID 32430583 ↗ May 2020 “(177Lu)-PSMA-617 will be administered every 6 weeks for up to 6 cycles per SOC.” NCT05613894 ↗ “177Lu-PSMA-617 is a nuclear medicine therapy.” NCT06320067 ↗ |
| Known as | 177Lu-DOTA-PSMA-617 | “177Lu-DOTA-PSMA-617 (177Lu-PSMA-617) is a PSMA-targeted small molecule with favorable properties and is the most extensively investigated PSMA radioligand for radionuclide...” PMID 31595044 ↗ Oct 2019 |
| Known as | 177Lu-PSMA-617 also referred to as 177Lu-PSMA | “177Lu-PSMA-617 also referred to as 177Lu-PSMA” NCT04343885 ↗ |
| Known as | 177Lutetium -PSMA 617 also referred to as 177Lu-PSMA | “177Lutetium -PSMA 617 also referred to as 177Lu-PSMA” NCT05150236 ↗ |
| Known as | 177Lutetium-PSMA-617 | “The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient...” NCT06783348 ↗ |
| Known as | [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 | “[177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 is a standard treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated...” PMID 39978808 ↗ Apr 20251“[177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 (177Lu-PSMA-617) is a novel treatment for metastatic castration-resistant prostate cancer.” PMID 41926960 ↗ Apr 2026 |
| Known as | [177Lu]Lu-PSMA-617 | “lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) significantly improved radiographic progression-free survival compared with change of androgen receptor pathway inhibitor (ARPI)” PMID 40441170 ↗ May 20251“[177Lu]Lu-PSMA-617 radiopharmaceutical therapy has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC)” PMID 40876952 ↗ Oct 2025 |
| Known as | Lutetium (177Lu) vipivotide tetraxetan | “lutetium (177Lu) vipivotide tetraxetan (Pluvicto®)” NCT06516510 ↗ |
| Known as | Lutetium Lu 177 vipivotide tetraxetan | “The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in...” NCT06943495 ↗ |
| Known as | Pluvicto | “The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in...” NCT06943495 ↗3“Androgen Receptor Pathway Inhibitors (ARPI), chemotherapy or Pluvicto (AAA617) at the discretion of the investigator” NCT07206056 ↗ “lutetium (177Lu) vipivotide tetraxetan (Pluvicto®)” NCT06516510 ↗ |
| Known as | vipivotide tetraxetan | “In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved radiographic...” PMID 37269841 ↗ Jun 20231“lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) significantly improved radiographic progression-free survival compared with change of androgen receptor pathway inhibitor (ARPI)” PMID 40441170 ↗ May 2025 |
| Action | Inhibit | “which is an inhibitor capable of binding to the domain of PSMA.” NCT03042312 ↗ |
| Modality | Other / unclassified | “Radioligand therapy (RLT) with 177Lu-PSMA-617 is a promising option” PMID 32430583 ↗ May 2020 |
| Route | Intravenous | “repeated intravenous (i.v.) injection” NCT03042312 ↗ |