Prostate Cancer Radioligand Therapy Pipeline
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 by April 27, 2026. As of April 27, 2026: Novartis has withdrawn its European Medicines Agency (EMA) application for an expanded indication of Pluvicto for pre-chemotherapy treatment of prostate-specific membrane antigen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) due to concerns about the PSMAfore study's control arm. However, the FDA expanded Pluvicto's approved indication on March 16, 2026, for adults with PSMA-positive mCRPC after ARPI therapy and before chemotherapy, based on the PSMAfore trial, which showed a 59% reduction in the risk of radiographic progression or death. Early data from a Phase 1 study of Actinium-225 FL-020 also shows promising safety and tolerability in mCRPC patients, with Convergent Therapeutics set to present Phase 2 data for CONV01-α at the 2026 ASCO Annual Meeting. Recent research indicates PSMA therapy can delay hormone therapy by an average of twenty months and double progression-free survival when used before other treatments.
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April 2026 — 7 developments
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.
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.
Novartis has withdrawn its European Medicines Agency (EMA) application for an expanded indication of…
Novartis has withdrawn its European Medicines Agency (EMA) application for an expanded indication of Pluvicto for pre-chemotherapy treatment of prostate-specific membrane antigen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.
Early data from a Phase 1 study of Actinium-225 FL-020, a PSMA-targeted alpha-emitting radioligand t…
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.
The Barbara Ann Karmanos Cancer Institute announced the expansion of access to radiopharmaceutical t…
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.
Janux Therapeutics has dosed the first patient in a Phase 1 trial for JANX014, a PSMA-targeted T-cell engager, advancing investigational PSMA-directed therapies.
Janux Therapeutics has dosed the first patient in a Phase 1 trial for JANX014, a PSMA-targeted T-cell engager, advancing investigational PSMA-directed therapies.
Novartis is investigating Pluvicto for earlier stages of prostate cancer, including metastatic hormo…
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.
A meta-analysis presented in February 2026 indicated that Pluvicto offers improved progression-free survival in advanced prostate cancer without increasing serious adverse events.
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
The FDA has expanded the approved indication for Pluvicto to include adults with PSMA-positive metas…
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.
The FDA has approved an expanded indication for Novartis' Pluvicto, allowing its use earlier in adva…
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.
A new PSMA-targeted radioligand therapy, when administered before stereotactic body radiotherapy, mo…
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.
Bayer has announced promising results from its Phase I PAnTHa study of 225Ac-PSMA-Trillium, an inves…
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
New findings from the PSMAddition study, presented at the 2026 Genitourinary Cancers Symposium, indi…
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.
Bayer presented data from its Phase I PAnTHa study of the investigational targeted alpha therapy 225…
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.
Curium presented pharmacokinetics and dosimetry data for its investigational lutetium-177 zadavotide guraxetan at the ASCO GU 2026 symposium.
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.
Novartis announced the construction of a new radioligand therapy (RLT) manufacturing facility in Denton, Texas, its fifth RLT site in the U.
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.
Novartis announced its intention to build a new radioligand therapy (RLT) manufacturing site in Denton, Texas, its fifth RLT facility in the U.
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.
New real-world data presented at the ASCO Genitourinary Cancers Symposium reinforce the earlier use …
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®).
Researchers have identified that certain genetic mutations, including TP53, PTEN, and RB1, are linke…
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.
A meta-analysis of over 2500 patients presented at the Multidisciplinary Radiopharmaceutical Therapy…
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.
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.
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.
Curium Group, in collaboration with PeptiDream Inc.
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).
Novartis announced that Pluvicto received MHRA approval in the UK on February 3, 2026, for a new indication.
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.
The American Society of Clinical Oncology (ASCO) has released its first living guidelines for prosta…
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.
Soon Chun Hyang University Hospital Bucheon became the first in Incheon and western Gyeonggi Province to offer Pluvicto therapy for advanced prostate cancer.
Soon Chun Hyang University Hospital Bucheon became the first in Incheon and western Gyeonggi Province to offer Pluvicto therapy for 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.
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
The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Ilumira (lut…
The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Ilumira (lutetium (177Lu) chloride), a radiopharmaceutical precursor used in radioligand therapies.
UCLA Health has initiated the Phase 2 ANDROMEDA clinical trial to investigate combined precision radiation and targeted radioactive therapy 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
A new clinical trial from UCLA Health found that adding PSMA-targeted radioligand therapy before ste…
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
New data from the Phase III PSMAddition study show that Pluvicto™ (lutetium 177 vipivotide tetraxeta…
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.
Novartis announced positive Phase III PSMAddition trial results, showing Pluvicto significantly dela…
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
Novartis' Pluvicto achieved sales of $454 million in Q2 2025, a 22% increase from the previous quart…
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
The FDA has expanded the indication for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include …
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.
April 2024 — 1 developments
Novartis announced its plans to file for Pluvicto's approval for earlier use (pre-chemotherapy) in t…
Novartis announced its plans to file for Pluvicto's approval for earlier use (pre-chemotherapy) in the second half of 2024, based on updated patient survival data from the PSMAfore trial.
October 2023 — 1 developments
Initial data from the Phase III PSMAfore trial were unveiled, demonstrating that Pluvicto met its primary endpoint of radiographic progression-free survival (rPFS).
Initial data from the Phase III PSMAfore trial were unveiled, demonstrating that Pluvicto met its primary endpoint of radiographic progression-free survival (rPFS).
August 2022 — 1 developments
Pluvicto received its first European approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain.
Pluvicto received its first European approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain.
May 2022 — 1 developments
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.
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
The Phase 3 VISION trial, evaluating 177Lu-PSMA-617, met its primary endpoints of overall survival a…
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
Novartis acquired Endocyte Inc.
Novartis acquired Endocyte Inc., thereby gaining the licensing rights to PSMA-617 and its development.
January 2014 — 1 developments
First clinical experiences with PSMA-617 in the diagnosis and radioligand therapy of prostate cancer…
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
The development of PSMA-617, the active compound in Pluvicto, began, building on earlier research into urea-based PSMA inhibitors from 2005.
The development of PSMA-617, the active compound in Pluvicto, began, building on earlier research into urea-based PSMA inhibitors from 2005.