Johnson & Johnson submits application to the European Medicines Agency seeking indication extension of AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
The results demonstrate significant and clinically meaningful benefits of the niraparib and abiraterone acetate plus prednisone or prednisolone regimen in delaying cancer progression and worsening of symptoms1
BEERSE, BELGIUM, July 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of an extension of indication application to the European Medicines Agency (EMA) seeking approval of AKEEGA® (niraparib and abiraterone acetate) with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and homologous recombination repair (HRR) gene alterations.
mHSPC is a form of prostate cancer that has spread to other parts of the body, but still responds to hormone therapy.2 While the treatment landscape has advanced in recent years, almost all patients eventually develop resistance to therapy, and the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive and currently incurable disease stage.3 Over 20 percent of patients with mHSPC have HRR gene alterations, including alterations in BRCA1/2, which have been shown to negatively impact outcomes.4 These patients have an unmet medical need which existing therapies do not address.4
'Despite significant progress in prostate cancer, individuals with HRR gene alterations often face limited treatment options, faster onset of symptoms and poorer outcomes,' said Henar Hevia, Ph.D., Senior Director, EMEA Therapy Area Head, Oncology, Johnson & Johnson Innovative Medicine. 'With this submission to the EMA, we have the opportunity to offer patients with HRR-mutated mHSPC a treatment specifically targeted to the underlying biology of their disease. Pending approval, this niraparib-based combination will help redefine the standard of care for this high-risk population, significantly delaying the time to their cancer progressing. This milestone reflects our commitment to advancing precision medicine in earlier stages of disease.'
The submission was supported by data from the Phase 3 AMPLITUDE study (NCT04497844), evaluating the efficacy and safety of niraparib and abiraterone acetate plus prednisone or prednisolone (AAP) for the treatment of patients with mHSPC with HRR gene alterations, versus placebo plus AAP.1,5 The study demonstrated clinically meaningful and statistically significant outcomes in the primary endpoint of radiographic progression-free survival (rPFS), and the key secondary endpoint of time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS) – highlighting the clinical benefits of niraparib and abiraterone acetate plus prednisone or prednisolone in delaying both cancer progression and the worsening of symptoms versus the current standard of care.1 AMPLITUDE is the first study to show the efficacy of combining a poly (ADP-ribose) polymerase (PARP) inhibitor and androgen receptor pathway inhibitor (ARPI) in this patient population.1
The safety profile of niraparib and abiraterone acetate plus prednisone or prednisolone is consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which niraparib and abiraterone acetate is currently approved.1,6 The most common Grade 3/4 adverse events (AEs) with the niraparib combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low.1
'At Johnson & Johnson, we remain committed to addressing the needs of individual patients by pushing the boundaries of science and innovation to deliver more personalised and effective treatment options at every stage of the prostate cancer journey,' said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine. 'The fixed dose combination of niraparib and abiraterone acetate has already had a positive impact in shifting the treatment paradigm for patients with metastatic castration-resistant prostate cancer, and we now look forward to extending this benefit to those with hormone-sensitive disease.'
Results from the AMPLITUDE study were presented as a late-breaking oral presentation (Abstract #LBA5006) at the 2025 American Society of Clinical Oncology Annual Meeting and selected for inclusion in the Best of ASCO and the ASCO Press Programme.1
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 androgen deprivation therapy (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).5 The primary endpoint is radiographic progression-free survival (rPFS).5 The study enrolled 696 participants from 32 countries.1
About Niraparib and Abiraterone Acetate This orally administered, dual action tablet (DAT) consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.5,7 Niraparib combined with abiraterone acetate and given with prednisone or prednisolone was approved in April 2023 in the European Economic Area for the treatment of patients with BRCA-mutated mCRPC6 in whom chemotherapy is not clinically indicated. Niraparib and abiraterone acetate is also approved in the USA, Canada, Switzerland, United Kingdom and many more. 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.8
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 still responds to ADT and has spread to other parts of the body.2
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/. Janssen-Cilag International NV, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies.
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.
© Janssen-Cilag International NV 2025. All rights reserved.
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References
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.
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 June 2025. Last accessed June 2025.
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.
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. doi: 10.1016/j.annonc.2025.05.534.
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 June 2025.
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 June 2025.
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 June 2025.
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 June 2025.
CP-526340
July 2025
CONTACT: Media contact: Laura Coughlan lcoughl5@its.jnj.com +358 87 147 9356 Investor contact: Raychel Kruper investor-relations@its.jnj.comSign in to access your portfolio
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