BEERSE, BELGIUM (30 January 2026) – Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an indication extension for AKEEGA® (niraparib and abiraterone acetate dual action tablet). The recommendation is for niraparib and abiraterone acetate with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT) and BRCA1/2 mutations (germline and/or somatic).
“Patients with metastatic hormone-sensitive prostate cancer who carry BRCA1/2 mutations face a more aggressive disease with survival outcomes that are significantly shorter, compared to those without these mutations, with limited treatment options before their disease progresses to metastatic castration-resistant prostate cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “Pending approval, the niraparib and abiraterone acetate dual action tablet will offer a targeted treatment strategy with the potential to address this urgent medical need earlier in the metastatic pathway, before the disease becomes more resistant.”
Most patients with metastatic hormone-sensitive prostate cancer (mHSPC) ultimately develop resistance to available therapies and progress to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive stage of disease with limited long-term survival.2 Approximately one in four patients with mHSPC harbour homologous recombination repair gene alterations (HRR) – most commonly BRCA1/2 – which are associated with faster disease progression and often shorter survival.3,4 As current mHSPC treatment approaches are not biomarker-selected and do not specifically address underlying DNA repair deficiencies, this high-risk population faces a significant unmet need for novel therapies.4,5
The CHMP recommendation is based on positive results from the Phase 3 AMPLITUDE study, which evaluated the efficacy and safety of the niraparib/AAP combination compared with placebo plus AAP in 696 patients with mHSPC and HRR gene alterations.1 The study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).1 Patients with BRCA1/2 mutations (n=191) showed the greatest benefit of treatment with the niraparib/AAP combination, as the median rPFS was not reached compared to 26 months in patients treated with the placebo plus AAP, reducing the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001).1 Treatment with the niraparib/AAP combination also significantly prolonged the time to symptomatic progression by 56 percent in patients with BRCA alterations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001).1 The first interim analysis showed an early trend toward improved overall survival favouring the niraparib/AAP combination, with a reduction in risk of death by 25 percent (HR 0.75, 95 percent CI, 0.51-1.11, p=0.15) in patients with BRCA alterations.1 Follow-up is ongoing for maturity of the data.6
The safety profile of the niraparib/AAP combination in mHSPC was consistent with that observed in mCRPC, for which the niraparib/AAP combination is currently authorised.1,7 The most common Grade 3/4 adverse events (AEs) with the niraparib/AAP combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low and AEs were manageable with dose modifications and supportive care.1
Data from the AMPLITUDE study were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and selected for inclusion in the Best of ASCO and ASCO Press Programme.8
“Building on our deep legacy spanning nearly two decades in the treatment of prostate cancer, we are driven by the belief that the next frontier of care requires more personalised treatment approaches that address the specific drivers of high-risk disease,” said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, Johnson & Johnson Innovative Medicine. “The combination of niraparib and abiraterone acetate represents an important step towards integrating targeted precision medicine into routine care, complementing our established apalutamide plus ADT option, a proven standard of care for the broader mHSPC patient population, reinforcing our commitment to delivering solutions across the prostate cancer continuum.”
About AMPLITUDE
AMPLITUDE (NCT04497844) is an ongoing, Phase 3, randomised, double-blind, placebo-controlled, international, multicentre study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual action tablet (DAT) formulation with prednisone plus ADT compared to matching oral placebo/abiraterone acetate in a DAT formulation with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic hormone-sensitive prostate cancer (mHSPC).6 The primary endpoint is radiographic progression-free survival (rPFS).6 The study enrolled 696 participants from 32 countries.1
About Niraparib and Abiraterone Acetate
This orally administered, DAT consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.6,9 Niraparib combined with abiraterone acetate and given with prednisone or prednisolone was authorised in April 2023 in the European Economic Area for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.7 Niraparib and abiraterone acetate is also approved in the USA, Canada, Switzerland, United Kingdom and many more countries. Additional marketing authorisation applications are under review across a number of countries globally.
In April 2016, Janssen Biotech, Inc. entered into a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2019), for exclusive rights to niraparib in prostate cancer.10
About Metastatic Hormone-Sensitive Prostate Cancer
Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.11
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://innovativemedicine.jnj.com/emea/. Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea/.
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 http://www.sec.gov, http://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.
Footnotes:
1 Attard G et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nature Medicine. 2025. 31:4109-4118.
2 Narayan V et al. Treatment patterns and survival outcomes among androgen receptor pathway inhibitor-experienced patients with metastatic castration-resistant prostate cancer. Clinical Genitourinary Cancer. 2024. 22(6):1-14.
3 Bilen M et al. Comparison of real-world outcomes between patients with BRCA1/2-positive and homologous recombination repair-negative metastatic castration-sensitive prostate cancer. Advances in Therapy. 2025. 42(8):3945-3959.
4 Olmos D et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Annals of Oncology. 2025. 36(10):1190-1202.
5 Yoo M et al. Cost-effectiveness analysis of 7 treatments in metastatic hormone-sensitive prostate cancer: a public-payer perspective. Journal of the National Cancer Institute. 2023. 115(11):1374-1382.
6 Clinicaltrials.gov. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for the treatment of participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) (AMPLITUDE). Available at: https://clinicaltrials.gov/study/NCT04497844. Last accessed January 2026.
7 Janssen EMEA. Janssen marks first approval worldwide for AKEEGA® (niraparib and abiraterone acetate dual action tablet) with EC authorisation for the treatment of patients with metastatic castration resistant prostate cancer with BRCA1/2 mutations. Available at: https://innovativemedicine.jnj.com/emea/janssen-marks-first-approval-worldwide-akeegar-niraparib-and-abiraterone-acetate-dual-action-tablet. Last accessed January 2026.
8 Attard G et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. 2025 American Society of Clinical Oncology Annual Meeting. 3 June 2025.
9 AKEEGA Summary of Product Characteristics. August 2024. Available at: https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf. Last accessed January 2026.
10 Johnsonandjohnson.gcs-web.com. Janssen enters worldwide collaboration and license agreement with TESARO, Inc., for niraparib in prostate cancer. Available at: https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/janssen-enters-worldwide-collaboration-and-license-agreement. Last accessed January 2026.
11 National Cancer Institute. Hormone-sensitive prostate cancer. Online. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hormone-sensitive-prostate-cancer. Last accessed January 2026.
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