Johnson & Johnson Secures CHMP Positive Opinion for AKEEGA®—a Dual-Action Tablet Combining Niraparib and Abiraterone Acetate—for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) in Patients with BRCA1/2 Mutations
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 CHMP 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 CHMP 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 CHMP 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 CHMP 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,CHMP 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 CHMP world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through CHMP 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.
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