The Medicines and Healthcare products Regulatory Agency (MHRA) grants marketing authorisation to AKEEGA^® (niraparib and abiraterone acetate) for adult patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)

This milestone marks the first precision medicine combination treatment to be licensed in the UK for patients with BRCA1/2-mutated mHSPC

Approximately one in ten patients with mHSPC harbour BRCA1/2 gene alterations, typically experiencing poorer outcome that those without, so highlighting the need for more personalised treatment approaches.^1,2

In patients with BRCA1/2-mutated mHSPC, AKEEGA® reduced the risk of radiographic progression or death by nearly half (48%) compared with the current standard of care (hazard ratio [HR] 0.52, 95% confidence interval [CI], 0.37-0.72, p<0.0001)^3,4,5

High Wycombe, UK (15 July 2026) – Johnson & Johnson (J&J) today announced that the MHRA has granted marketing authorisation for AKEEGA® (niraparib and abiraterone acetate dual-action pill), with prednisone or prednisolone, in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic). The decision means the UK has licensed the first precision medicine combination for patients with BRCA1/2-mutated mHSPC, marking an important step towards more personalised care and potential future NHS access for eligible patients across the UK.

Expert and company perspective on the MHRA marketing authorisation

“Whilst outcomes for advanced prostate cancer have improved notably over the last decade, prostate cancers with a BRCA mutation, which account for about one in ten cases, still have shorter survival and worse outcomes,” said Professor Gerhardt Attard, Director of the University College London Cancer Institute and Medical Oncology Consultant at University College London Hospitals NHS Foundation Trust.* “Targeted treatments with poly-ADP ribose polymerase (PARP) inhibitors have had a big impact for breast and ovarian cancers when optimised for use early on in the treatment paradigm. I’m delighted that we now have the potential to benefit this group of patients with a poorer prognosis.”

This announcement represents an important step forward for men in the UK with BRCA1/2-mutated mHSPC,” said Dr John Fleming, Country Medical Director, Johnson & Johnson Innovative Medicine UK. “These patients haven’t historically had a treatment option tailored to the underlying biology of their disease. This authorisation expands the use of precision medicine to an earlier stage of BRCA1/2-mutated prostate cancer and provides a new treatment option that enables care to be tailored to the underlying biology of the disease.

Following MHRA authorisation, J&J will continue to work with relevant health technology assessment bodies and healthcare stakeholders to support potential future access for eligible patients across the UK.

Unmet need in mHSPC patients

Prostate cancer is the most diagnosed cancer in men in the UK, with about 64,000 men diagnosed every year,⁶ and around 20% presenting with metastatic disease.⁷ The majority of cases are hormone-sensitive, with between 8% and 12% of patients with mHSPC having BRCA1/2 gene alterations.^1,5

Patients with BRCA1/2 mutations often experience more aggressive disease, faster progression and shorter survival than those without these alterations.¹
This represents a significant unmet need that is not adequately addressed by existing treatment approaches.

#ENDS#

About the AMPLITUDE study
AMPLITUDE is a Phase 3, randomised, double-blind, placebo-controlled, multinational study evaluating treatment with AKEEGA® of niraparib and abiraterone acetate, with prednisone, versus abiraterone acetate, with prednisone (standard of care) in 696 patients with metastatic hormone-sensitive prostate cancer (mHSPC) and deleterious germline or somatic homologous recombination repair (HRR) gene alterations.^4,5 Patients were randomised (1:1) to receive either niraparib and abiraterone acetate, with prednisone (N=348), or placebo and abiraterone acetate, with prednisone (N=348), orally daily.^4,5

The primary endpoint was radiographic progression free survival (rPFS), defined as the time interval from the date of randomisation to the date of investigator-assessed first radiographic progression, or death due to any cause, whichever occurred first.^4,5 Secondary endpoints included time to symptomatic progression and overall survival.^4,5

Results showed that after 30.7 months of follow-up, the median rPFS was not reached in patients treated with niraparib and abiraterone acetate, with prednisone (n=191) compared with 26 months for patients treated with abiraterone acetate, with prednisone (n=196), corresponding to a significant reduction in the risk of rPFS by 48% (hazard ratio [HR] 0.52, 95% confidence interval [CI], 0.37-0.72, p<0.0001).^4,5 Niraparib and abiraterone acetate, with prednisone, also significantly prolonged the time to symptomatic progression (HR 0.44, 95% CI, 0.29-0.68, p=0.0001), versus abiraterone acetate, with prednisone, and prolonged overall survival, with a 20% reduction in the risk of death (HR 0.80, 95% CI, 0.58-1.11), versus abiraterone acetate, with prednisone.^4,5

The most common adverse events of all grades occurring in >10% of the niraparib and abiraterone acetate, with prednisone, arm (n=347) were anaemia (51.9%), hypertension (40.1%), fatigue (39.7%), musculoskeletal pain (35.8%) and constipation (34.7%). Serious adverse reactions occurred in 39% of patients treated with niraparib and abiraterone acetate, with prednisone (n=347).^4,5 The most frequently observed grade 3-4 adverse reactions in the niraparib and abiraterone acetate, with prednisone, arm were anaemia (29.7%), hypertension (22.7%), hypokalaemia (9.3%), neutropenia (8.4%), thrombocytopenia (7.5%) and lymphopenia (5.2%).^4,5

See SmPC for full safety information including contraindications and warnings.

About AKEEGA^®
In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer. This dual-action tablet combines niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.^4,5 Niraparib prevents tumour cells from repairing damaged DNA.^4,5 In BRCA-mutated tumour cells, the cancer can no longer effectively repair its DNA and eventually dies.^4,5 Abiraterone acetate reduces the production of androgens, hormones that can drive tumour growth. Together, these complementary mechanisms of action provide a precision-based treatment approach for eligible patients with BRCA1/2-mutated mHSPC.^4,5

In the UK, niraparib and abiraterone acetate is already licensed with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.^8,9

About metastatic hormone-sensitive prostate cancer
Metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that has spread beyond the prostate to other parts of the body but still responds to hormone therapy (androgen deprivation therapy [ADT]).¹ While the treatment landscape has advanced in recent years, almost all mHSPC patients eventually develop resistance to therapy, and the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive and currently incurable stage, where the disease continues to grow despite testosterone-lowering treatment.¹

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/innovativemedicine/uk
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© Janssen-Cilag Limited, a Johnson & Johnson Company. All rights reserved.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of niraparib and abiraterone acetate. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

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*Professor Gerhardt Attard has served as a consultant to Johnson & Johnson; she has not been paid for any media work.