HORSHAM, PA, October 16, 2025 – The U.S. Food and Drug Administration (FDA) granted Priority Review to Johnson & Johnson for its supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA-mutated metastatic castration-sensitive prostate cancer (mCSPC). Patients with BRCA mutations have a poor prognosis, representing a significant unmet medical need not addressed by currently available therapies.1
The sNDA is supported by data from the Phase 3 AMPLITUDE study, which demonstrated that treatment with AKEEGA® plus prednisone reduced 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) in patients with BRCA-mutated mCSPC.2 It also significantly prolonged the time to symptomatic progression by 56 percent (HR 0.44; 95 percent CI, 0.29–0.68; p=0.0001) and showed a trend toward improved overall survival (OS), with a 25 percent reduction in the risk of death (HR 0.75; 95 percent CI, 0.51–1.11; p=0.15).2
In the AMPLITUDE study, the most common Grade 3/4 adverse events in patients with BRCA-mutated mCSPC were anemia (53.9 percent vs 25.5 percent) and hypertension (47.1 percent vs 32.1 percent) in the niraparib and abiraterone group versus abiraterone.2
If approved, AKEEGA® plus prednisone would be the first PARP-based precision medicine combination treatment for this patient population. Patients with BRCA-mutated mCSPC experience approximately 50 percent faster disease progression and shorter survival—highlighting the importance of early genetic testing to inform treatment decisions and the urgent need for novel targeted therapies to delay disease progression and improve outcomes for patients.3
About AMPLITUDE
AMPLITUDE (
NCT04497844) is an ongoing, Phase 3, randomized, double-blind, placebo-controlled, multicenter, global 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 with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). The primary endpoint is radiographic progression-free survival (rPFS). The study enrolled 696 participants from 32 countries.
About Metastatic Castration-Sensitive Prostate Cancer
Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that has spread to other parts of the body but still responds to hormone therapy (androgen deprivation therapy).4 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.5 Approximately 25 percent of patients with mCSPC have HRR gene alterations, including BRCA, which have been shown to negatively impact outcomes.1,6 Patients with BRCA mutations have a poor prognosis, representing a significant unmet medical need not addressed by currently available therapies.1
About AKEEGA® (niraparib and abiraterone acetate)
AKEEGA® is a dual-action tablet (DAT), combining niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor. AKEEGA® together with prednisone or prednisolone was approved in
April 2023 by the European Medicines Agency, and in
August 2023 by the U.S. FDA following Priority Review, for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Patients are selected for therapy based on an FDA-approved test for genetic alterations. Additional marketing authorization applications are under review across a number of countries globally.
In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer.
For more information visit www.akeegahcp.com/.
AKEEGA® IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
The safety population described in the WARNINGS and PRECAUTIONS reflect exposure to AKEEGA® in combination with prednisone in BRCAm patients in Cohort 1 (N=113) of MAGNITUDE.
Myelodysplastic Syndrome/Acute Myeloid Leukemia AKEEGA® may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).
MDS/AML, including cases with fatal outcome, has been observed in patients treated with niraparib, a component of AKEEGA®.
All patients treated with niraparib who developed secondary MDS/cancer-therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.
For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue AKEEGA® if MDS/AML is confirmed.
Myelosuppression
AKEEGA® may cause myelosuppression (anemia, thrombocytopenia, or neutropenia).
In MAGNITUDE Cohort 1, Grade 3-4 anemia, thrombocytopenia, and neutropenia were reported, respectively in 28%, 8%, and 7% of patients receiving AKEEGA®. Overall, 27% of patients required a red blood cell transfusion, including 11% who required multiple transfusions. Discontinuation due to anemia occurred in 3% of patients.
Monitor complete blood counts weekly during the first month of AKEEGA® treatment, every two weeks for the next two months, monthly for the remainder of the first year and then every other month, and as clinically indicated. Do not start AKEEGA® until patients have adequately recovered from hematologic toxicity caused by previous therapy. If hematologic toxicities do not resolve within 28 days following interruption, discontinue AKEEGA® and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.
Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions
AKEEGA® may cause hypokalemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. In post-marketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalemia while taking abiraterone acetate, a component of AKEEGA®. Hypertension and hypertensive crisis have also been reported in patients treated with niraparib, a component of AKEEGA®.
In MAGNITUDE Cohort 1, which used prednisone 10 mg daily in combination with AKEEGA®, Grades 3-4 hypokalemia was detected in 2.7% of patients on the AKEEGA® arm and Grades 3-4 hypertension were observed in 14% of patients on the AKEEGA® arm.
The safety of AKEEGA® in patients with New York Heart Association (NYHA) Class II to IV heart failure has not been established because these patients were excluded from MAGNITUDE.
Monitor patients for hypertension, hypokalemia, and fluid retention at least weekly for the first two months, then once a month. Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia, or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. Control hypertension and correct hypokalemia before and during treatment with AKEEGA®.
Discontinue AKEEGA® in patients who develop hypertensive crisis or other severe cardiovascular adverse reactions.
Hepatotoxicity
AKEEGA® may cause hepatotoxicity.
Hepatotoxicity in patients receiving abiraterone acetate, a component of AKEEGA®, has been reported in clinical trials. In post-marketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure, and deaths.
In MAGNITUDE Cohort 1, Grade 3-4 ALT or AST increases (at least 5 x ULN) were reported in 1.8% of patients. The safety of AKEEGA® in patients with moderate or severe hepatic impairment has not been established as these patients were excluded from MAGNITUDE.
Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with AKEEGA®, every two weeks for the first three months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring and may require dosage modifications.
Permanently discontinue AKEEGA® for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation, or in patients who develop ALT or AST ≥20 x ULN at any time after receiving AKEEGA®.
Adrenocortical Insufficiency
AKEEGA® may cause adrenal insufficiency.
Adrenocortical insufficiency has been reported in clinical trials in patients receiving abiraterone acetate, a component of AKEEGA®, in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with abiraterone acetate. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased doses of corticosteroids may be indicated before, during, and after stressful situations.
Hypoglycemia
AKEEGA® may cause hypoglycemia in patients being treated with other medications for diabetes.
Severe hypoglycemia has been reported when abiraterone acetate, a component of AKEEGA®, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide.
Monitor blood glucose in patients with diabetes during and after discontinuation of treatment with AKEEGA®. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.
Increased Fractures and Mortality in Combination with Radium 223 Dichloride
AKEEGA® with prednisone is not recommended for use in combination with Ra-223 dichloride outside of clinical trials.
The clinical efficacy and safety of concurrent initiation of abiraterone acetate plus prednisone/prednisolone and radium Ra 223 dichloride was assessed in a randomized, placebo-controlled multicenter study (ERA-223 trial) in 806 patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer with bone metastases. The study was unblinded early based on an Independent Data Monitoring Committee recommendation.
At the primary analysis, increased incidences of fractures (29% vs 11%) and deaths (39% vs 36%) have been observed in patients who received abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride compared to patients who received placebo in combination with abiraterone acetate plus prednisone.
It is recommended that subsequent treatment with Ra-223 not be initiated for at least five days after the last administration of AKEEGA®, in combination with prednisone.
Posterior Reversible Encephalopathy Syndrome
AKEEGA® may cause Posterior Reversible Encephalopathy Syndrome (PRES).
PRES has been observed in patients treated with niraparib as a single agent at higher than the recommended dose of niraparib included in AKEEGA®.
Monitor all patients treated with AKEEGA® for signs and symptoms of PRES. If PRES is suspected, promptly discontinue AKEEGA® and administer appropriate treatment. The safety of reinitiating AKEEGA® in patients previously experiencing PRES is not known.
Embryo-Fetal Toxicity
The safety and efficacy of AKEEGA® have not been established in females. Based on animal reproductive studies and mechanism of action, AKEEGA® can cause fetal harm and loss of pregnancy when administered to a pregnant female.
Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow).
In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (AUC) at the recommended dose.
Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of AKEEGA®. Females who are or may become pregnant should handle AKEEGA® with protection, e.g., gloves.
Based on animal studies, AKEEGA® may impair fertility in males of reproductive potential.
ADVERSE REACTIONS
The safety of AKEEGA® in patients with BRCAm mCRPC was evaluated in Cohort 1 of MAGNITUDE.
The most common adverse reactions (≥10%), including laboratory abnormalities, are decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST, increased ALT, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, increased bilirubin, weight decreased, arrhythmia, fall, and pyrexia.
Serious adverse reactions reported in >2% of patients included COVID-19 (7%), anemia (4.4%), pneumonia (3.5%), and hemorrhage (3.5%). Fatal adverse reactions occurred in 9% of patients who received AKEEGA®, including COVID-19 (5%), cardiopulmonary arrest (1%), dyspnea (1%), pneumonia (1%), and septic shock (1%).
DRUG INTERACTIONS
Effect of Other Drugs on AKEEGA®
Avoid coadministration with strong CYP3A4 inducers.
Abiraterone is a substrate of CYP3A4. Strong CYP3A4 inducers may decrease abiraterone concentrations, which may reduce the effectiveness of abiraterone.
Effects of AKEEGA® on Other Drugs
Avoid coadministration unless otherwise recommended in the Prescribing Information for CYP2D6 substrates for which minimal changes in concentration may lead to serious toxicities. If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug.
Abiraterone is a CYP2D6 moderate inhibitor. AKEEGA® increases the concentration of CYP2D6 substrates, which may increase the risk of adverse reactions related to these substrates.
Monitor patients for signs of toxicity related to a CYP2C8 substrate for which a minimal change in plasma concentration may lead to serious or life-threatening adverse reactions.
Abiraterone is a CYP2C8 inhibitor. AKEEGA® increases the concentration of CYP2C8 substrates, which may increase the risk of adverse reactions related to these substrates.
Please see the full Prescribing Information for AKEEGA®.
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://www.jnj.com/ or at
www.innovativemedicine.jnj.com. Janssen Research & Development, LLC, and Janssen Biotech, Inc., 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 AKEEGA®. 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 materialize, 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 behavior 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 www.sec.gov, 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 Olmos D, Lorente D, Jambrina A, et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Ann Oncol. 2025;36(10):1190-1202. doi:10.1016/j.annonc.2025.05.534
2 Attard G, Agarwal N, Graff JN, 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.
3 Olmos, D. (2025, May). Impact of somatic/germline homologous recombination repair (HRR) alterations on metastatic hormone-sensitive prostate cancer (mHSPC) outcomes by disease volume. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025.
4 National Cancer Institute. Hormone-sensitive prostate cancer. Accessed October 2025. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hormone-sensitive-prostate-cancer
5 Narayan V, Patel MY, Teitsson S, et al. Treatment patterns and survival outcomes among androgen receptor pathway inhibitor-experienced patients with metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2024;22(6):102188. doi:10.1016/j.clgc.2024.102188
6 Gonzalez D, Mateo J, Stenzinger A, et al. Practical considerations for optimising homologous recombination repair mutation testing in patients with metastatic prostate cancer. J Pathol Clin Res. 2021;7(4):311-325. doi:10.1002/cjp2.203