U.S. FDA Approves AKEEGA®—First Precision Therapy for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer, Cutting Disease Progression by 54% Compared to Standard of Care*
Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approvedthe supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).1 Patients with BRCA mutations often have more aggressive forms of prostate cancer leading to poor prognosis, representing a significant unmet need not addressed by previously available therapies.2
“There remains an urgent need for novel therapies for patients with BRCA2-mutated mCSPC, who face significantly faster disease progression and often shorter survival compared to those without the mutation,” said Bradley McGregor, M.D., Director of Clinical Research for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute. “AMPLITUDE is the first study to show that this precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor delays both radiographic and symptomatic disease progression.”
The approval is based on positive results from AMPLITUDE (NCT04497844), a randomized, double-blind, placebo-controlled, international Phase 3 clinical study. In patients with BRCA2-mutated mCSPC, treatment with AKEEGA® plus prednisone and androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 54 percent (hazard ratio [HR] 0.46; 95 percent confidence interval [CI], 0.32–0.66) compared to placebo/abiraterone acetate plus prednisone and ADT, which is the current standard of care.1 AKEEGA® plus prednisone and ADT also significantly prolonged the time to symptomatic progression by 59 percent (HR 0.41; 95 percent CI, 0.29–0.65).1
The observed safety profile of the combination of AKEEGA® plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. In the AMPLITUDE clinical study, the most common adverse reactions (≥20%) including laboratory abnormalities, were decreased hemoglobin, decreased lymphocytes, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, decreased aspartate aminotransferase, fluid retention/edema, increased bilirubin, respiratory tract infection and arrhythmia.1
“This expanded indication for AKEEGA reflects our commitment to push the boundaries of science and deliver more personalized, effective treatment options across the prostate cancer continuum,” said Mahadi Baig, M.D., M.H.C.M., Vice President, Head of Solid Tumors, U.S. Medical Affairs, Johnson & Johnson Innovative Medicine. “Supported by strong clinical data, AKEEGA is now the first and only PARP-based precision medicine combination treatment in BRCA2-mutated mCSPC, offering patients hope for more time with a new way to potentially delay their cancer from progressing.”
Johnson & Johnson is committed to helping patients access our treatments. Once a patient and their doctor have decided that AKEEGA® is right for the patient, J&J withMe provides a simple, comprehensive patient support program offering cost support and educational resources, at no cost to the patient.
*The hazard ratio [HR] 0.46; 95 percent confidence interval [CI], 0.32–0.66) compared to standard of care, AKEEGA® plus prednisone and ADT also significantly prolonged the time to symptomatic progression by 59 percent (HR 0.41; 95 percent CI, 0.29–0.65).1
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).3 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.4
Approximately 25 percent of patients with mCSPC have HRR gene alterations, including BRCA, which have been shown to negatively impact outcomes.2,5 Patients with BRCA mutations experience approximately 50 percent faster disease progression and shorter survival, representing a significant unmet medical need not addressed by previously available therapies.2
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).
AKEEGA® plus prednisone was approved by the U.S. FDA in December 2025 under Priority Review for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). 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.
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