Prostate Cancer Radioligand Therapy Pipeline

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SUMMARY

Novartis discontinued its radioligand therapy (RLT) candidate, Lutetium-NeoB (Lu-NeoB), on July 21, 2026, due to early clinical data not supporting further development, while reaffirming its commitment to RLT and highlighting Pluvicto's strong performance with a 43% sales increase to $651 million in Q2 2026. As of July 29, 2026, research is progressing in alpha-emitting therapies, with Novartis advancing 225Ac-PSMA-617, and SHINE Technologies opening a large Lu-177 production facility to meet growing demand. Telix Pharmaceuticals dosed the first patients in its OPTIMAL-e trial for metastatic hormone-sensitive prostate cancer and achieved a regulatory milestone with the FDA aligning on its Phase 3 trial protocol for TLX591-Tx. Lutetium-177 PSMA-617 shows promise in earlier stages of prostate cancer, achieving a progression-free survival of 31.0 months when combined with standard therapy, compared to 20.2 months with standard therapy alone.

Timeline

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July 2026 — 19 developments

  1. New Radioligand Therapy Research Explores Alpha Emitters and Expands Lutetium-177 Production

    Research is progressing in alpha-emitting therapies like Actinium-225 and Lead-212 to overcome resistance to beta-emitters, with Novartis advancing its candidate 225Ac-PSMA-617. SHINE Technologies has opened a large Lu-177 production facility to support growing demand for radioligand therapies. The PSMAddition trial evaluated adding Pluvicto to standard therapy in metastatic hormone-sensitive prostate cancer.

  2. Novartis, Curium, Telix, and Lantheus Report New Radioligand Therapy Developments

    Curium presented pharmacokinetic and dosimetry data for its investigational Lu-177 zadavotide guraxetan, supporting further clinical development. Telix Pharmaceuticals' TLX591-Tx achieved a regulatory milestone with the FDA aligning on its Phase 3 trial protocol. Lantheus received FDA tentative approval for Lutetium Lu 177 Dotatate (PNT2003).

  3. Novartis publishes TLX591-Tx trial results, discontinues Lu-NeoB, Pluvicto sales grow

    Results from the ProstACT SELECT phase 1 trial for TLX591-Tx, a PSMA-targeting radio antibody-drug conjugate, have been published, suggesting it has a manageable safety profile and prolonged tumor retention. Novartis has discontinued its Phase 2 radioligand therapy (RLT) candidate, Lutetium-NeoB (Lu-NeoB), due to early clinical data not supporting further development. The company reaffirmed its commitment to RLT, highlighting the strong performance of Pluvicto, which saw a 43% sales increase to $651 million in the second quarter.

  4. Novartis Expands RLT Supply Chain in Korea; New Trials and Research Show Promise for Prostate Cancer Therapy

    Telix Pharmaceuticals has dosed the first patients in its OPTIMAL-e trial investigating an adaptive-dosed PSMA-targeted radioligand therapy for metastatic hormone-sensitive prostate cancer (mHSPC). New research indicates PSMA therapy can delay hormone therapy by approximately twenty months for patients with limited metastatic prostate cancer. Novartis is also establishing a radioligand therapy supply chain in Korea.

  5. Pluvicto Anticipates FDA Approval for Prostate Cancer in Q3 2026; Therapy Now Available Locally

    Novartis anticipates FDA approval for Pluvicto in metastatic hormone-sensitive prostate cancer in Q3 2026. Flagstaff Medical Center has launched Pluvicto therapy, making it locally available for eligible patients with advanced prostate cancer.

  6. Radioligand Therapy Shows Promise in Earlier Prostate Cancer Stages

    Lutetium-177 PSMA-617, a radioligand therapy, is showing promise in earlier stages of prostate cancer, specifically metastatic hormone-sensitive prostate cancer (mHSPC). Studies indicate that when combined with docetaxel and androgen deprivation therapy (ADT), it achieved a progression-free survival of 31.0 months compared to 20.2 months with standard therapy alone. The therapy also showed predominantly mild side effects and could potentially reduce the need for lifelong hormone therapy.

  7. Novartis Discontinues Lu-NeoB Radioligand Therapy Studies Due to Clinical Data

    Novartis has discontinued all studies of its GRPR-targeting therapy, Lu-NeoB, due to early clinical data not supporting advancement. The company stated its continued commitment to radioligand therapy (RLT) despite this decision. This occurred on July 21, 2026.

  8. New Radioligand Therapy Trials Begin; Pluvicto Submissions Filed in US, China, Japan

    Telix Pharmaceuticals dosed the first patient in its Phase 3 LUTEON trial for renal cell carcinoma and the OPTIMAL-e trial for prostate cancer. Immunome, Inc. dosed the first patient in a Phase 1 trial for IM-3050, an FAP-targeted radioligand therapy. Regulatory submissions for Pluvicto's expanded use have been filed in the U.S., China, and Japan, with decisions expected in the second half of 2026. Novartis has discontinued development of its Lutetium-NeoB candidate but reaffirmed its commitment to radioligand therapies.

  9. Bruce Power Completes Hot Cell Facility; New Prostate Cancer Trial Doses First Patients

    Bruce Power has completed its on-site hot cell facility, a significant step in the production of lutetium-177 for targeted radionuclide therapy. Additionally, the OPTIMAL-e trial has dosed its first patients to evaluate an adaptive-dosed investigational PSMA-targeted radioligand therapy for metastatic hormone-sensitive prostate cancer.

  10. NICE Unable to Recommend Pluvicto for Prostate Cancer Due to Missing Submission

    NICE was unable to recommend Pluvicto for a specific indication because Novartis did not provide an evidence submission. This decision follows previous FDA approval expansions and trial data highlighting Pluvicto's efficacy in treating prostate cancer.

  11. Pluvicto Shows Effectiveness in mCRPC Patients Previously Treated with Sipuleucel-T, New Data Suggests

    New real-world data presented at the 2026 Genitourinary Cancers Symposium suggests that Pluvicto remains effective in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with sipuleucel-T. The study indicated a median overall survival of 19.8 months and progression-free survival of 15.2 months in this patient population.

  12. New Alpha-Emitter Radiopharmaceutical Trial Begins Dosing for Prostate Cancer

    A Phase 1 clinical trial, ACT-RESoLUTE, has begun dosing patients with metastatic castration-resistant prostate cancer (mCRPC) using an investigational alpha-emitting radiopharmaceutical targeting PSMA. The study aims to assess safety, tolerability, and antitumor activity.

  13. GE HealthCare, Mayo Clinic Launch Prostate Cancer Radioligand Therapy Study; Novartis Withdraws EU Application for Pluvicto

    GE HealthCare and Mayo Clinic have launched a new research collaboration, MI-BET, to explore personalized radioligand therapy for advanced prostate cancer. Separately, Novartis has withdrawn its EU application for Pluvicto's earlier prostate cancer treatment expansion but presented new data from the PSMAddition trial supporting its use in hormone-sensitive prostate cancer, showing a 58% reduction in PSA progression when combined with standard hormonal therapy.

  14. Prostate Cancer Radioligand Therapy Sees New Trial Updates and FDA Decision Date

    Convergent Therapeutics' CONV01-α has a PDUFA target decision date of August 28, 2026, from the FDA, as research into new radioligands and radionuclides continues. New findings indicate PSMA therapy can delay hormone therapy by an average of twenty months in men with limited metastatic prostate cancer. Updates from the 2026 PSMA & Beyond Conference show significant improvement in radiographic progression-free survival with the addition of 177Lu-PSMA-617 to standard therapy in metastatic hormone-sensitive prostate cancer.

  15. Radioligand Therapy Market Projected to Reach $10.5 Billion by 2030; Guidelines Updated

    The radioligand therapy market is projected to reach $10.5 billion by 2030, driven by advancements in isotopes and ligands. Additionally, the 2026 AUA/SUO Advanced Prostate Cancer Guideline now recommends PSMA-PET imaging more preferentially, reflecting expanded indications for ¹⁷⁷Lu-PSMA-617 based on the PSMAfore trial.

  16. Blue Earth Therapeutics Starts Phase 2 Trial; UCLA Study Shows Improved Survival with 177Lu-PSMA Combo Therapy

    Blue Earth Therapeutics has initiated a Phase 2 clinical trial for Lutetium (177Lu) rhPSMA-10.1 injection for metastatic castration-resistant prostate cancer (mCRPC). Additionally, new clinical trial results from UCLA Health show that adding 177Lu-PSMA before stereotactic body radiotherapy (SBRT) more than doubled progression-free survival in patients with recurrent prostate cancer compared to SBRT alone.

  17. Telix Pharmaceuticals Gains FDA Alignment for Phase 3 Trial of Prostate Cancer Therapy

    Telix Pharmaceuticals has announced alignment with the FDA on its ProstACT Global Phase 3 trial for TLX591-Tx, a lutetium-177 therapeutic candidate for metastatic castration-resistant prostate cancer. The FDA confirmed that safety data from Part 1 of the study is sufficient to advance Part 2 of the trial into the U.S. This development allows the trial to proceed to its next phase in the United States.

  18. Asia-Pacific Region Faces Challenges in Building Radioligand Therapy Industry

    The Asia-Pacific region faces significant hurdles in establishing a domestic radioligand therapy industry, primarily due to challenges in owning isotopes and managing their short half-lives. Lutetium-177, a key isotope for treatments like Pluvicto, has a half-life of approximately 6.6 days, requiring complex multi-day production and separation processes.

  19. Novartis Pluvicto Receives FDA Priority Review for Expanded Prostate Cancer Indication

    Novartis has received FDA acceptance for priority review of its supplemental new drug application for Pluvicto to expand its indication to include metastatic hormone-sensitive prostate cancer (mHSPC). The FDA is expected to make a decision on the application in the second half of 2026.

June 2026 — 15 developments

  1. New Study Links Interim PET Scans to Prostate Cancer Radioligand Therapy Outcomes

    A new study published in The Journal of Nuclear Medicine indicates that interim 18F-FDG PET/CT scans can assess treatment response for advanced prostate cancer patients undergoing 177Lu-PSMA therapy. Disease progression on PET scans was found to correlate with poorer outcomes. The research also featured studies on somatostatin PET imaging for breast cancer and a new PET tracer for staph infections.

  2. Novartis Projects $5B Pluvicto Sales; Guidelines Expand Therapy Use Amid Supply Chain Fears

    Novartis anticipates Pluvicto sales to reach $5 billion by 2030, despite supply chain challenges exacerbated by geopolitical events. The updated AUA/SUO Advanced Prostate Cancer Guideline now includes an expanded indication for Pluvicto in metastatic castration-resistant prostate cancer. Geopolitical conflicts and export restrictions are creating supply chain challenges for necessary radioactive isotopes for radioligand therapy.

  3. Novartis-Sponsored Radioligand Therapy Trial for HER2-Positive Cancers Launched at MUHC

    The McGill University Health Centre (MUHC) has launched the world's first Phase I clinical trial for HER2-positive cancers using a novel radioligand therapy sponsored by Novartis. This trial will assess the safety and potential of this approach in patients with metastatic HER2-positive cancers that have progressed despite existing treatments.

  4. Novartis Pluvicto Gets Priority Review in Japan; European Societies Optimize Radioligand Therapy Access

    Novartis's Pluvicto has received Priority Review in Japan for PSMA-positive metastatic castration-resistant prostate cancer. Six European medical societies have launched a project to optimize referral pathways for prostate cancer radioligand therapy, aiming to improve equitable access across the continent.

  5. Prostate Cancer Radioligand Therapy Outcomes Influenced by Patient Factors, ASCO Analysis Shows

    A real-world analysis presented at the 2026 ASCO Annual Meeting indicates that patient factors such as comorbidity burden, tobacco exposure, and baseline laboratory markers influence overall survival outcomes for lutetium (Lu177) vipivotide tetraxetan treatment in prostate cancer. These findings suggest that physiologic reserve and systemic inflammatory state may meaningfully impact results with PSMA-targeted radioligand therapy.

  6. Novartis Launches Pluvicto, First Radioligand Therapy for Prostate Cancer in India

    Novartis India has launched Pluvicto, the country's first approved radioligand therapy for eligible prostate cancer patients. This precision radiotherapy targets cancer cells while minimizing harm to healthy tissues, offering a new treatment for metastatic prostate cancer.

  7. Novartis resolves Pluvicto supply shortage and seeks label expansion for prostate cancer therapy

    Novartis has resolved the supply shortage of Pluvicto, more than doubling production capacity and expecting continued expansion. The company is also pursuing label expansion for Pluvicto in metastatic hormone-sensitive prostate cancer, with regulatory decisions anticipated in the second half of 2026.

  8. Pluvicto Gains Expanded FDA Indication; Prior Vaccination May Boost Radioligand Therapy Efficacy

    Novartis's Pluvicto has received an expanded FDA indication for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed on androgen receptor pathway inhibitors and are candidates for delayed chemotherapy. Emerging research presented at SNMMI suggests prior vaccination for prostate cancer-specific antigens may double the rate of two-year overall survival in mCRPC patients treated with 177Lu-PSMA-617.

  9. Novartis Files Pluvicto Submissions, Withdraws EU Application; Tunisia Produces Radiopharmaceutical

    Novartis has filed for regulatory submissions for Pluvicto in the US, China, and Japan, with decisions anticipated in the second half of 2026. The company also withdrew its EU label expansion application for Pluvicto in March 2026. Meanwhile, Tunisia began national production of 18F-PSMA in March 2026, and Actinium Pharmaceuticals presented new preclinical data for ATNM-400.

  10. PSMAfore Trial Results Published in The Lancet Show Improved Survival for mCRPC Patients

    The PSMAfore trial results, published in The Lancet, demonstrate that ¹⁷⁷Lu-PSMA-617 significantly prolonged progression-free survival in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC). Additionally, a novel theranostic approach targeting the rearranged during transfection (RET) biomarker could help treat PSMA-negative neuroendocrine prostate cancer, offering a potential new avenue for patients with this subtype.

  11. Novartis Pluvicto Data Shows Doubled Progression-Free Survival in Prostate Cancer Trial

    Novartis presented updated data from the PSMAfore trial at ASCO 2026, showing Pluvicto (lutetium PSMA-617) more than doubled median radiographic progression-free survival (rPFS) compared to a change in androgen receptor pathway inhibitor (ARPI) in men with metastatic castration-resistant prostate cancer (mCRPC) who progressed on ARPI and were chemotherapy-naïve.

  12. Radioligand Therapy Advances: New Doses Established and Novel Approaches Introduced for Prostate Cancer

    The Phase 1 AcTION trial has established a recommended Phase 2 dose (RP2D) for 225Ac-PSMA-617, an alpha-emitting radioligand therapy, demonstrating a manageable safety profile and promising responses in metastatic castration-resistant prostate cancer patients. New subgroup analyses from the Phase 3 PSMAddition trial indicate that adding Pluvicto to standard therapies provides a survival benefit. A novel theranostic approach targeting RET for neuroendocrine prostate cancer was also introduced, expanding therapeutic options for patients with limited imaging visualization.

  13. Telix Pharmaceuticals and Novartis Present New Prostate Cancer Radioligand Therapy Data at ASCO 2026

    Telix Pharmaceuticals presented positive Phase 3 ProstACT Global Study data for its PSMA-targeted lutetium radio antibody-drug conjugate, TLX591-Tx, at ASCO 2026, indicating an acceptable safety profile. Novartis also shared new data from the Phase III PSMAddition trial, showing Pluvicto significantly reduced the risk of PSA progression in metastatic hormone-sensitive prostate cancer.

  14. Prostate Cancer Radioligand Therapy Sees New Data, FDA Response

    Convergent Therapeutics announced positive Phase 2 data for CONV01-α in metastatic castration-resistant prostate cancer patients. Novartis presented promising Phase 1 data for investigational actinium-based radioligand therapies, and the PSMAfore trial showed ¹⁷⁷Lu-PSMA-617 extended time before cancer progression. Separately, Novartis received a Complete Response Letter from the FDA regarding its supplemental New Drug Application for Pluvicto.

  15. SHINE Technologies Secures EU Market Authorization for Lutetium-177; Convergent Presents Phase 2 Data

    SHINE Technologies secured EU market authorization for its radioisotope product Ilumira (non-carrier-added lutetium-177), broadening access to Lu-177 for targeted radioligand therapies. Convergent Therapeutics presented promising Phase 2 data for CONV01-α in metastatic castration-resistant prostate cancer patients. Curium is investing over €32 million in France to establish a European production line for 177Lu-PSMA-I&T.

May 2026 — 6 developments

  1. Novartis Presents New Radioligand Therapy Data; ML Approach to Personalize PSMA Dosing; Isotope Facility Planned

    Novartis presented early data at ASCO 2026 showing their investigational actinium-based radioligand therapy, 225Ac-PSMA-617, demonstrated anti-tumor activity in prostate cancer patients, including those previously treated with Pluvicto. Separately, a new machine-learning approach presented at the Society of Nuclear Medicine and Molecular Imaging 2026 Annual Meeting could personalize PSMA therapy dosing by estimating radiation dose to tumors and healthy organs. Eden Radioisotopes has also filed an application to construct a new facility in New Mexico to increase the domestic supply of medical isotopes like lutetium-177.

  2. AI Prostate Test Launched to Personalize Therapy Intensity for mHSPC Patients

    Tempus AI has launched the ArteraAI Prostate Test, an AI-powered tool that analyzes clinical data and biopsy images to estimate the risk of prostate cancer-specific mortality. This development personalizes therapy intensity for patients with metastatic hormone-sensitive prostate cancer (mHSPC).

  3. Pluvicto Sales Surged to $2 Billion in 2025 Amidst Expanded Use Push

    Pluvicto sales reached $2 billion in 2025, marking a 43% year-over-year increase. Novartis is pursuing expanded use in metastatic hormone-sensitive prostate cancer (mHSPC) based on positive Phase III PSMAddition trial data, with decisions anticipated in the second half of 2026 for submissions in the U.S., China, and Japan.

  4. FDA Expands Label for Prostate Cancer Therapy; New Real-World Data on Pluvicto Released

    The U.S. Food and Drug Administration (FDA) has expanded the label for gallium Ga-68 gozetotide (Illuccix) to include patient selection for PSMA-targeted radioligand therapy before taxane-based chemotherapy in men with mCRPC. Real-world studies also indicate Pluvicto achieved longer progression-free survival when initiated after one androgen receptor pathway inhibitor rather than multiple.

  5. Novartis Files for Pluvicto Expansion in mHSPC, Presents New Trial Data

    Novartis has filed supplemental new drug applications in the US, China, and Japan for Pluvicto in metastatic hormone-sensitive prostate cancer (mHSPC), with decisions anticipated in the second half of 2026. New data from the Phase III PSMAddition trial showed a 58% lower risk of PSA progression when Pluvicto is combined with standard of care in PSMA-positive mHSPC patients.

  6. Telix Pharmaceuticals Advances Next-Gen PSMA Therapies; Pluvicto Combo Shows Promise

    Telix Pharmaceuticals is developing next-generation PSMA-targeted therapies, including TLX597-Tx, with early dosimetry data suggesting low uptake in salivary glands and kidneys. Research also highlights that a combination therapy of Pluvicto and stereotactic body radiotherapy (SBRT) shows potential in delaying progression in recurrent prostate cancer, and early SPECT/CT imaging after Pluvicto treatment may predict long-term survival in mCRPC patients.

April 2026 — 7 developments

  1. Novartis expands Pluvicto infrastructure; PSMA therapy shows promise in earlier prostate cancer stages

    Novartis is expanding its infrastructure, including a new plant in California, to meet anticipated demand for Pluvicto, projecting over $5 billion in annual product revenues. Recent research also indicates that PSMA therapy is effective in earlier prostate cancer stages, potentially delaying hormone therapy by an average of twenty months and doubling progression-free survival when used before other treatments.

  2. Novartis withdraws Pluvicto expanded indication application in Europe

    Novartis has withdrawn its European Medicines Agency (EMA) application for an expanded indication of Pluvicto for pre-chemotherapy treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). This decision follows feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) regarding concerns about the control arm of the PSMAfore study.

  3. New PSMA-Targeted Radioligand Therapies Show Early Promise in mCRPC Trials

    Early data from a Phase 1 study of Actinium-225 FL-020, a PSMA-targeted alpha-emitting radioligand therapy, shows promising safety and tolerability in patients with metastatic castration-resistant prostate cancer (mCRPC). Convergent Therapeutics will present Phase 2 data for its PSMA-targeted actinium-225 (Ac-225) radioantibody, CONV01-α, at the 2026 ASCO Annual Meeting.

  4. Karmanos Cancer Institute Expands Radiopharmaceutical Therapies to More Michigan Locations

    The Barbara Ann Karmanos Cancer Institute announced the expansion of access to radiopharmaceutical therapies, including Pluvicto, to additional Karmanos Cancer Network locations in Michigan. This expansion aims to provide more targeted treatment options for oncology patients with metastasized disease.

  6. Novartis investigates Pluvicto for earlier prostate cancer stages, starts new T-cell engager trial

    Novartis is investigating Pluvicto for earlier stages of prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC), showing significant improvement in radiographic progression-free survival. A Phase 1 trial for a new PSMA-targeted T-cell engager has also commenced for patients with mCRPC.

  7. Studies show Pluvicto improves prostate cancer survival and delays hormone therapy

    A meta-analysis presented in February 2026 indicated that Pluvicto offers improved progression-free survival in advanced prostate cancer without increasing serious adverse events. Furthermore, a study published in March 2026 in The Lancet Oncology demonstrated that PSMA therapy can effectively postpone the need for more burdensome hormone therapy in patients with limited metastatic prostate cancer, delaying it by an average of twenty months.

March 2026 — 4 developments

  1. FDA expands Pluvicto approval for prostate cancer; Novartis faces supply issues; Telix advances TLX-591-Tx

    The FDA has expanded the approved indication for Pluvicto to include adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with ARPI therapy and are considered appropriate to delay taxane-based chemotherapy. Telix Pharmaceuticals is advancing its PSMA-targeted radiopharmaceutical, TLX-591-Tx, and plans to submit data to the FDA. Novartis is experiencing supply chain issues for its lutetium-177 radiopharmaceutical treatment but is working to expedite the approval of an additional manufacturing facility.

  2. FDA approves expanded use of Novartis' Pluvicto for earlier prostate cancer treatment

    The FDA has approved an expanded indication for Novartis' Pluvicto, allowing its use earlier in advanced prostate cancer treatment, specifically after ARPI therapy and before chemotherapy. This decision, based on the Phase 3 PSMAfore trial, potentially triples the number of eligible patients by demonstrating a 59% reduction in the risk of radiographic progression or death.

  3. New Radioligand Therapy Doubles Progression-Free Survival in Recurrent Prostate Cancer

    A new PSMA-targeted radioligand therapy, when administered before stereotactic body radiotherapy, more than doubled progression-free survival in patients with recurrent prostate cancer, extending it from 7.4 months to 17.6 months. This combination therapy reduced the risk of cancer returning, the need for hormone therapy, or death by 63%. Patients also experienced a significant delay in starting hormone therapy, with a median of 24.3 months compared to 14.1 months in the control group.

  4. Bayer announces promising Phase I results for prostate cancer therapy 225Ac-PSMA-Trillium

    Bayer has announced promising results from its Phase I PAnTHa study of 225Ac-PSMA-Trillium, an investigational targeted alpha therapy for advanced metastatic castration-resistant prostate cancer. The study demonstrated significant antitumor activity, with a 62% PSA response rate and a 50% overall response rate across all doses, and notably, an 83% PSA50 response rate and 71% overall response rate at the 125 kBq/kg dose.

February 2026 — 14 developments

  1. Pluvicto maintains quality-of-life in prostate cancer patients in PSMAddition study

    New findings from the PSMAddition study, presented at the 2026 Genitourinary Cancers Symposium, indicate that Pluvicto (lutetium Lu 177 vipivotide tetraxetan) combined with androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) maintained quality-of-life outcomes in patients with metastatic hormone-sensitive prostate cancer. This was compared to ADT plus an ARPI alone, with a median follow-up of 23.6 months.

  2. Bayer presented positive Phase I data for 225Ac-PSMA-Trillium in prostate cancer

    Bayer presented data from its Phase I PAnTHa study of the investigational targeted alpha therapy 225Ac-PSMA-Trillium for advanced metastatic castration-resistant prostate cancer at the 2026 ASCO Genitourinary Cancers Symposium. The results support advancing this therapy to the next phase of development, positioning it as a strategic pillar in Bayer's precision oncology efforts for mCRPC patients.

  3. Curium presented lutetium-177 zadavotide guraxetan pharmacokinetics and dosimetry data at ASCO GU 2026

    Curium presented pharmacokinetics and dosimetry data for its investigational lutetium-177 zadavotide guraxetan at the ASCO GU 2026 symposium. The data from a substudy of the Phase 3 ECLIPSE trial showed projected mean cumulative renal doses remained low for PSMA-targeted radioligand therapy in metastatic castration-resistant prostate cancer patients.

  4. Novartis announces new radioligand therapy facility in Texas, presents Pluvicto data

    Novartis announced the construction of a new radioligand therapy (RLT) manufacturing facility in Denton, Texas, its fifth RLT site in the U.S., expected to be operational by 2028. New real-world data presented at the ASCO Genitourinary Cancers Symposium reinforce the earlier use of Pluvicto before chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), showing a median progression-free survival (PFS) of 13.5 months in chemo-naïve patients. Additionally, researchers identified genetic mutations (TP53, PTEN, RB1) linked to inferior overall survival in Pluvicto-treated patients.

  5. Novartis announces new radioligand therapy manufacturing site in Denton, Texas

    Novartis announced its intention to build a new radioligand therapy (RLT) manufacturing site in Denton, Texas, its fifth RLT facility in the U.S. The new 46,000-square-foot facility, expected to be operational by 2028, is part of Novartis's $23 billion investment in the U.S. and aims to expand their capacity for producing next-generation treatments.

  6. Prostate Cancer Foundation announces $10 million gift for Pluvicto resistance research

    New real-world data presented at the ASCO Genitourinary Cancers Symposium reinforce the earlier use of Pluvicto before chemotherapy in metastatic castration-resistant prostate cancer (mCRPC), demonstrating a median progression-free survival (PFS) of 13.5 months in chemo-naïve patients. Separately, the Prostate Cancer Foundation announced a $10 million gift to launch the TACTICAL Award, which will focus on understanding and overcoming resistance to 177Lu-PSMA-617 (Pluvicto®).

  7. Researchers link TP53, PTEN, RB1 mutations to inferior Pluvicto survival in prostate cancer

    Researchers have identified that certain genetic mutations, including TP53, PTEN, and RB1, are linked to inferior overall survival in patients treated with Pluvicto (lutetium-177 PSMA-617) for advanced prostate cancer. A study involving 72 patients found these mutations may serve as prognostic biomarkers for treatment outcomes.

  8. Pluvicto significantly improves progression-free survival in advanced prostate cancer patients

    A meta-analysis of over 2500 patients presented at the Multidisciplinary Radiopharmaceutical Therapy Symposium showed that Pluvicto (Lu-177 PSMA-617) significantly improved progression-free survival (PFS) in advanced prostate cancer patients compared to standard treatment. The study found no increase in adverse events for patients receiving Pluvicto. Pooled results presented at the American Society for Radiation Oncology's symposium also indicated Pluvicto consistently prolongs PFS.

  9. Eli Lilly halts development of prostate cancer therapy AC-225-PSMA-62 due to efficacy concerns

    Eli Lilly has ceased development of three therapies, including a radioligand therapy (AC-225-PSMA-62) that was in a Phase I/II trial for prostate cancer. The decision to terminate the development was based on efficacy concerns, with safety not being a factor.

  10. Curium Group Initiates Registrational Clinical Trial for 177Lu-PSMA-I&T in Japan

    Curium Group, in collaboration with PeptiDream Inc. and PDRadiopharma Inc., has initiated a registrational clinical trial for 177Lu-PSMA-I&T in Japan. The first patient has been dosed in this Phase 2 trial, which will evaluate the efficacy of the treatment for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

  11. Novartis' Pluvicto receives MHRA approval for earlier mCRPC treatment in UK

    Novartis announced that Pluvicto received MHRA approval in the UK on February 3, 2026, for a new indication. This expanded approval allows Pluvicto to be administered to eligible patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) earlier in their treatment pathway, specifically after progression on or after androgen receptor pathway inhibitor (ARPI) therapy and when delaying taxane-based chemotherapy is considered appropriate.

  12. ASCO releases first living guidelines for prostate cancer, allowing Pluvicto use before chemotherapy

    The American Society of Clinical Oncology (ASCO) has released its first living guidelines for prostate cancer, which now allow for Pluvicto to be used before chemotherapy in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Novartis is also pursuing an expanded label for Pluvicto to include patients in the pre-taxane chemotherapy setting.

  14. Kai Tsao to debate optimal timing for Lutetium-177 therapy in advanced prostate cancer

    Kai Tsao of Northwell Health Cancer Institute is scheduled to participate in a debate discussing the optimal timing for Lutetium-177 (Pluvicto) therapy in advanced prostate cancer. The discussion will focus on the potential advantages of earlier use of the radioligand therapy.

January 2026 — 2 developments

  2. UCLA Health Initiates Phase 2 ANDROMEDA Clinical Trial for Recurrent Prostate Cancer

    UCLA Health has initiated the Phase 2 ANDROMEDA clinical trial to investigate combined precision radiation and targeted radioactive therapy for recurrent prostate cancer. The study will compare lutetium-177–PSMA-617 and actinium-225–PSMA-617.

November 2025 — 1 developments

  1. UCLA Health trial delays prostate cancer progression with new combination therapy

    A new clinical trial from UCLA Health found that adding PSMA-targeted radioligand therapy before stereotactic body radiotherapy significantly delays disease progression in men with recurrent prostate cancer. This combination therapy showed promising results in improving patient outcomes.

October 2025 — 2 developments

  1. Novartis reports Pluvicto significantly reduces progression or death in prostate cancer

    New data from the Phase III PSMAddition study show that Pluvicto™ (lutetium 177 vipivotide tetraxetan) in combination with standard of care significantly reduced the risk of progression or death by 28% compared to standard of care alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). Novartis also presented promising trial results at ESMO for Pluvicto in mHSPC when combined with standard hormonal therapy, showing an early positive trend in reducing cancer progression.

  2. Novartis announces Pluvicto significantly delayed prostate cancer progression in mHSPC

    Novartis announced positive Phase III PSMAddition trial results, showing Pluvicto significantly delayed progression to end-stage prostate cancer in metastatic hormone-sensitive prostate cancer (mHSPC).

July 2025 — 1 developments

  1. Novartis' Pluvicto sales jump 22% to $454M in Q2 2025 after FDA approval

    Novartis' Pluvicto achieved sales of $454 million in Q2 2025, a 22% increase from the previous quarter, boosted by an FDA approval in pre-taxane metastatic castration-resistant prostate cancer (mCRPC). In 2025, Novartis also submitted an FDA filing for Pluvicto in PSMA-positive metastatic hormone-sensitive prostate cancer.

March 2025 — 1 developments

  1. FDA expands Pluvicto indication for metastatic prostate cancer

    The FDA has expanded the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have undergone androgen receptor pathway inhibitor (ARPI) therapy. Additionally, data from the PSMAfore clinical trial support the use of 177Lu-PSMA-617 as a new standard treatment for this patient population.

June 2024 — 1 developments

  1. New Prostate Cancer Radioligand Therapy Data Shows Enhanced Pluvicto Efficacy and Promising New Agents

    A retrospective study presented at SNMMI 2026 indicated that prior vaccination for prostate cancer-specific antigens was associated with a significantly higher likelihood of PSA50 response and a reduction in mortality risk when combined with Pluvicto in patients with metastatic castration-resistant prostate cancer (mCRPC). Actinium Pharmaceuticals presented new preclinical data on ATNM-400, demonstrating superior efficacy compared to PSMA-617 radioligands in prostate cancer cells resistant to approved androgen receptor inhibitors. Convergent Therapeutics announced interim data from its Phase 2 CONVERGE-01 study of Ac-225 rosopatamab tetraxetan, showing promising anti-tumor activity, durability, and a favorable tolerability profile in patients previously treated with Lu-177-PSMA.

April 2024 — 1 developments

October 2023 — 1 developments

August 2022 — 1 developments

May 2022 — 1 developments

  1. Novartis Suspends Production at Radioligand Therapy Sites Due to Quality Issues

    Novartis announced a temporary, voluntary suspension of production at its radioligand therapy sites in Ivrea, Italy, and Millburn, New Jersey, due to potential quality issues. This action led to a temporary suspension of Pluvicto (177Lu-PSMA-617) delivery in the US and a hold on clinical trials for the drug.

March 2021 — 1 developments

  1. VISION Trial Meets Primary Endpoints in Prostate Cancer Study

    The Phase 3 VISION trial, evaluating 177Lu-PSMA-617, met its primary endpoints of overall survival and radiographic progression-free survival in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

January 2018 — 1 developments

January 2014 — 1 developments

  1. ABX advanced biochemical compounds GmbH licenses PSMA-617 for prostate cancer diagnosis and therapy

    First clinical experiences with PSMA-617 in the diagnosis and radioligand therapy of prostate cancer were obtained, and the compound was subsequently licensed to ABX advanced biochemical compounds GmbH.

January 2012 — 1 developments