On March 9, 2026 Johnson & Johnson reported 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).

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"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) (Free ASCO Whitepaper) Annual Meeting and selected for inclusion in the Best of ASCO (Free ASCO Whitepaper) and ASCO (Free ASCO Whitepaper) 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.

(Press release, Johnson & Johnson, MAR 9, 2026, View Source [SID1234663393])