BEERSE, BELGIUM (9 March 2026) – Johnson & Johnson today announced that the European Commission (EC) has approved an indication extension for AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic).
“Patients with BRCA-mutated metastatic prostate cancer often experience rapid progression on the current standard of care, highlighting a significant unmet need for more personalised treatment approaches that address the underlying biology of their disease,” said Dr. Elena Castro, Medical Oncologist, Hospital 12 de Octubre, Madrid* “Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression.”
AMPLITUDE efficacy results
The approval is supported by data 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 homologous recombination repair (HRR) gene alterations.1 The primary analysis of 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 showed the greatest benefit of treatment with the niraparib/AAP combination (n=191), as after 30.7 months of follow-up, the median rPFS was not yet reached compared to 26 months in patients treated with the placebo plus AAP (n=196), corresponding to a reduction in 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).1,3 Treatment with the niraparib/AAP combination also significantly prolonged the time to symptomatic progression in patients with BRCA mutations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001).1 The second interim analysis of overall survival was consistent with the first interim analysis and favoured the niraparib/AAP combination, with a 20 percent reduction in risk of death (HR 0.80, 95 percent CI, 0.58-1.11) in patients with BRCA mutations.3 Follow-up is ongoing.4
“This expanded indication for niraparib and abiraterone acetate reflects our commitment to delivering transformative innovation across the prostate cancer continuum,” said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, Johnson & Johnson. “Niraparib and abiraterone acetate is the first precision-medicine combination treatment approved for patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer and is supported by strong clinical data demonstrating a clinically meaningful delay in disease progression.”
AMPLITUDE safety results
The safety profile of the niraparib/AAP combination in mHSPC was consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which the niraparib/AAP combination is already authorised.1,5 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 adverse events were managed 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.6
“Today’s EC approval shifts the treatment paradigm and brings new hope to those facing a metastatic prostate cancer diagnosis,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. “By bringing niraparib and abiraterone acetate earlier into the treatment pathway, in the hormone-sensitive setting, we can intervene at a point where it may have the greatest impact in helping change the trajectory of the disease for patients with BRCA1/2-mutated tumours.”
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).4 The primary endpoint is radiographic progression-free survival (rPFS).4 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.3,4 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.5 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.7
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using niraparib and abiraterone acetate, please refer to the Summary of Product Characteristics.3
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.8
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.
*Dr. Elena Castro has served as a consultant to Johnson & Johnson; they have not been paid for any media work.
Foonotes
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 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.
3 European Medicines Agency. AKEEGA Summary of Product Characteristics. February 2026.
4 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 March 2026.
5 Johnson & Johnson. 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://www.jnj.com/media-center/press-releases/janssen-marks-first-approval-worldwide-for-akeega-niraparib-and-abiraterone-acetate-dual-action-tablet-with-ec-authorization-for-the-treatment-of-patients-with-metastatic-castration-resistant-prostate-cancer-with-brca1-2-mutations. Last accessed March 2026.
6 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.
7 Investor.jnj.com. Janssen enters worldwide collaboration and license agreement with TESARO, Inc., for niraparib in prostate cancer. Available at: https://www.investor.jnj.com/investor-news/news-details/2016/Janssen-Enters-Worldwide-Collaboration-and-License-Agreement-with-TESARO-Inc.-for-Niraparib-in-Prostate-Cancer-04-06-2016/default.aspx. Last accessed March 2026.
8 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 March 2026.
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