Novartis Pluvicto (lutetium (177Lu) vipivotide tetraxetan)▼ receives MHRA authorisation for new indication for eligible patients with PSMA‑positive metastatic castration‑resistant prostate cancer

• New indication authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) expands access to lutetium177 vipivotide tetraxetan in the UK for eligible mCRPC patients earlier in the treatment pathway, following progression on or after androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.1
• Patients with mCRPC often face a challenging trade-off between maintaining quality of life and controlling their disease. There remains an unmet need for therapies that can delay disease progression and postpone the need for chemotherapy, without compromising quality of life.
• The MHRA approval is based on Phase III PSMAfore clinical trial results demonstrating a statistically significant improvement in radiographic progression free survival, with a 59% reduction in risk of radiographic progression or death vs ARPI change (hazard ratio [HR] 0·41 [95% CI 0·29–0·56]; p<0·0001).2

London, February 3, 2026 – Novartis announced that Pluvicto® (lutetium-177 vipivotide tetraxetan) has received MHRA approval for a new indication for adult patients with prostate specific membrane antigen (PSMA)–positive metastatic castration resistant prostate cancer (mCRPC) who have progressed on or after androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane based chemotherapy.1 This approval means that lutetium-177 vipivotide tetraxetan can now be administered to eligible patients earlier in the treatment pathway.

According to Prostate Cancer UK latest research 64,425 people were diagnosed with the disease in 2022, making prostate cancer the most common cancer in the UK3. Some diagnosed patients may eventually progress to mCRPC once the disease spreads and no longer responds to androgen deprivation therapy. Although hormone therapies and chemotherapy are available treatment options in the UK, they may not be appropriate for all, and many patients and their healthcare providers may consider avoiding or delaying chemotherapy.

“The MHRA licence update supports clinicians in tailoring care to individual needs, delaying progression while helping maintain quality of life. For a disease where treatment alternatives narrow with each line of therapy, introducing another option before chemotherapy represents progress for patients. At Novartis, we remain committed to advancing new solutions for people living with prostate cancer, and this milestone reflects that dedication,” said Rob Hastings, Chief Medical Officer, Novartis UK.

The MHRA licence is based on the results of Phase III PSMAfore clinical trial, which evaluated the treatment option for expanded indication. In the study lutetium177 vipivotide tetraxetan extended the median time to disease progression or death vs ARPI change by 3.7 months (9.3 vs. 5.6 months respectively) HR 0.41; 95% CI: 0.29, 0.56; p<0.0001) compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy.2

In the PSMAfore Trial, the median overall survival (OS) was 24.48 months (95% CI 19.55-28.94 months) with 177Lu-PSMA-617 and 23.13 months (19.61-25.53 months) with ARPI change (HR 0.91, 95% CI 0.72-1.14, P = 0.20) based on the intended to treat (ITT) principle. The OS analysis was confounded by the high rate of patients who crossed over from the control arm to Pluvicto (60.3%). When adjusted for crossover, the OS hazard ratio was 0.59 (95% CI: 0.38, 0.91) with the inverse probability of censoring weighting (IPCW) method.4 The key secondary endpoint of overall survival did not achieve statistical significance.

Additional findings from the PSMAfore trial showed lutetium-177 vipivotide tetraxetan demonstrated an acceptable safety profile. The most frequently reported all-grade adverse events for Pluvicto were primarily Grade 1-2 and included dry mouth (58%), fatigue (23%), nausea (32%), and constipation (22%). Lutetium-177 vipivotide tetraxetan did not impair the ability of patients to be treated with subsequent chemotherapy.4

Novartis remains committed to advancing prostate cancer care and is working with healthcare system leaders to make radioligand therapies accessible to more patients living with the disease.

About the PSMAfore study
PSMAfore (NCT04689828) is a Phase III, open-label, multi-center, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI (abiraterone or enzalutamide) in patients with PSMA-positive mCRPC who have not been exposed to a taxane-containing regimen. Patients enrolled must have progressed only once after receiving a second-generation ARPI (abiraterone, enzalutamide, darolutamide or apalutamide).

Patients randomised to the change in the ARPI arm were allowed to crossover to receive Pluvicto upon confirmation of radiographic progression by blinded independent central review (BICR). There were 468 participants enrolled in the study.

The primary endpoint is rPFS, defined as the time from randomisation to radiographic progression by PCWG3-modified RECIST v1.1 (as assessed by BICR) or death. The key secondary endpoint of OS is defined as the time from date of randomisation until the date of death due to any cause. The pre-specified crossover-adjusted OS analysis was performed using the rank-preserving structural failure time (RPSFT) model to adjust for crossover.2

About Pluvicto® (lutetium Lu 177 vipivotide tetraxetan)
Lutetium Lu 177 vipivotide tetraxetan is an intravenous radioligand therapy (RLT) combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Lutetium binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.

In two Phase III studies (VISION and PSMAfore), lutetium (177Lu) vipivotide tetraxetan demonstrated statistically significant improvements in rPFS compared with control.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. 

In the UK, we champion health and lives through pioneering NHS partnerships, innovative collaborations and a clear focus on the greatest healthcare challenges we all face. We are where science meets hope.

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