Akeega (abiraterone/niraparib) / J&J - LARVOL DELTA

On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test (FDA) - "Efficacy was evaluated in AMPLITUDE (NCT04497844), a randomized, double-blind trial in 696 patients with homologous recombination repair (HRR) gene-mutated (HRRm) mCSPC."

FDA approval • Prostate Cancer

HARMONY: Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Qian Qin | N=64 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Niraparib/Abiraterone Acetate Combo Maintains Baseline HR-QOL in HRRM+ mHSPC (Cancer Network) - "HR-QOL FACT-P scores remained comparable across arms overall after following a similar pattern as FACT-G scores in the first 4 cycles. The mean baseline FACT-P score for the experimental arm was 113.3 (SD, 20.2) and 112.7 (SD, 20.4) in the placebo arm. The overall LS mean change from baseline in FACT-P scores was -0.05 (SE, 0.67) in the niraparib arm vs 1.22 (SE, 0.67) in the placebo arm (P = 0.181)....Scores on the FACT-P physical well-being subscale followed the same trend, with the scores varying in the first 4 cycles but remaining similar overall. The mean baseline scores here were 23.5 (SD, 4.6) in the niraparib arm and 23.6 (SD, 4.4) in the placebo arm. The overall LS mean change from baseline was -0.43 (SE, 0.15) in the experimental arm compared with -0.01 (SE, 0.15;) in the placebo arm (P = .0467)."

P3 data • Patient reported outcomes • Hormone Sensitive Prostate Cancer

Johnson & Johnson receives U.S. FDA Priority Review for AKEEGA (niraparib and abiraterone acetate dual-action tablet) in BRCA-mutated metastatic castration-sensitive prostate cancer (J&J Press Release) - "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."

Priority review • Hormone Sensitive Prostate Cancer

Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial (Nature) - "The primary endpoint was met, with a significant improvement in radiographic progression-free survival observed first in the BRCA subgroup (median not reached at the time of analysis for the niraparib and AAP group versus 26 months for the AAP group; hazard ratio = 0.52; 95% confidence interval: 0.37–0.72; P < 0.0001) and then in the intention-to-treat population (hazard ratio = 0.63; 95% confidence interval: 0.49–0.80; P = 0.0001). The data for overall survival, a key secondary endpoint, are immature (193/389 events) but favor niraparib (hazard ratio = 0.79 (95% confidence interval: 0.59–1.04); BRCA subgroup: hazard ratio = 0.75 (95% confidence interval: 0.51–1.11))....There were 14 treatment-emergent adverse events leading to deaths in the niraparib group and seven in the placebo group."

P3 data • Hormone Sensitive Prostate Cancer

HARMONY: Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations (clinicaltrials.gov) - P2 | N=64 | Suspended | Sponsor: Qian Qin | Recruiting ➔ Suspended

Trial suspension • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

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 (GlobeNewswire) - "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....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."

EMA filing • Hormone Sensitive Prostate Cancer • Prostate Cancer

Dr Morgans Provides Prostate Cancer Updates From ASCO 2025 (Targeted Oncology) - "Alicia Morgans, MD, MPH, discusses a potentially practice-changing abstract from the 2025 American Society of Clinical Oncology Annual Meeting: the AMPLITUDE trial."

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Niraparib/Abiraterone Is Effective for HRR+ Metastatic Castration-Sensitive Prostate Cancer (OncLive) - P3 | N=696 | AMPLITUDE (NCT04497844) | Sponsor: Janssen Research & Development, LLC | "The addition of the PARP inhibitor niraparib (Zejula) to abiraterone acetate (Zytiga) and prednisone (AAP) reduced the risk of radiographic progression or death by 37% compared with AAP and placebo for patients with metastatic castration-sensitive prostate cancer (mCSPC) with alterations in homologous recombination repair (HRR) genes following prior androgen deprivation therapy (ADT), according to findings from the phase 3 AMPLITUDE trial (NCT04497844) presented at the 2025 ASCO Annual Meeting...After a median follow-up of 30.8 months, the median radiographic progression-free survival (rPFS) was not estimable in the niraparib group compared with 29.5 months in the placebo arm (HR, 0.63; 95% CI, 0.49-0.80; P = .0001)....Overall survival (OS) was not statically significant at the analysis, with trends beginning to emerge showing improvement with niraparib (HR, 0.79; 95% CI, 0.59-1.04; P = .10)."

P3 data • Hormone Sensitive Prostate Cancer • Prostate Cancer

Accelerating Oncology Drug Reimbursement in Canada: Impact of the CDA-AMC Time-Limited Recommendation and pCPA Temporary Access Process. (PubMed, Curr Oncol) - " Nine oncology NOC/c were granted during the selected period, of which three products, Columvi, Akeega, and Epkinly, received provincial listings, and the median time from regulatory approvals to provincial listings is 509 days (IQ range 306-544 days). No acceleration in each agency's review time was observed. Participation in the TLR-pTAP pathway can help mitigate concerns over uncertainties associated with novel therapies while providing timelier access for patients with life-threatening diseases."

Journal • Reimbursement • US reimbursement • Oncology

HARMONY: Niraparib, Abiraterone Acetate and Prednisone for MHSPC with Deleterious Homologous Recombination Repair Alterations (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Qian Qin | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • SPOP

CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2025 ➔ Sep 2025 | Trial primary completion date: Dec 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • SPOP

Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC (flcube.com) - "Johnson & Johnson...has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations, germline and/or somatic. This marks Akeega as the first-and-only dual action tablet (DAT) of its kind in China....Akeega’s marketing approval in China follows its approval in the US in August of last year, highlighting the drug’s potential to become a standard of care for patients with mCRPC and BRCA1/2 mutations globally."

China approval • Castration-Resistant Prostate Cancer

Poland Publishes List of Drugs Excluded From Emergency Access Funding (NAVLIN DAILY) - "The Ministry of Health has released a list of medications excluded from reimbursement under the Emergency Access to Drug Technologies procedure (RDTL). Key drugs on the list include: (i) Akeega (niraparib / abiraterone acetate) for patients who have genetic mutations known as BRCA 1/2 mutations and who cannot have chemotherapy; (ii) Ayvakyt (avapritinib) used in adults to treat systemic mastocytosis, a blood disorder where the body makes too many abnormal mast cells (a type of white blood cell), which can build up in the skin, bones, joints, lymph nodes, liver, spleen, the stomach and gut."

Reimbursement • Aggressive Systemic Mastocytosis • Metastatic Castration-Resistant Prostate Cancer

LUNAAR: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Baptist Health South Florida | N=30 ➔ 0 | Trial completion date: Jul 2028 ➔ Oct 2028 | Initiation date: Jul 2024 ➔ Oct 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jul 2026 ➔ Oct 2026

Enrollment change • Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

STAMPEDE2: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov) - P3 | N=8000 | Recruiting | Sponsor: University College, London | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

U.S. Food and Drug Administration (FDA) Approves FoundationOne Liquid CDx as a Companion Diagnostic for AKEEGA (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer (Businesswire) - "Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne Liquid CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC)."

Diagnostic • FDA event • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

HARMONY: Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Qian Qin

Metastases • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

LUNAAR: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Rohan Garje

Metastases • New P1/2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

STAMPEDE2: A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (clinicaltrials.gov) - P3 | N=8000 | Not yet recruiting | Sponsor: University College, London

Metastases • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Korean government stalls access to PARP inhibitors for prostate cancer patients (Korea Biomedical Review) - "Currently, there are two PARP inhibitors available for prostate cancer treatment in Korea -- olaparib and niraparib....Lynpaza is already actively distributed in Korea with multiple indications, including ovarian, breast, and pancreatic cancers, as well as prostate cancer. However, Akeega has not decided on its launching schedule since it won approval from the Ministry of Food and Drug Safety in September last year....PARP inhibitors can't receive a reimbursement review unless the existing 'abiraterone + prednisolone' combination therapy is converted to full reimbursement (5/100)....Even if the selective reimbursement issue for abiraterone is resolved, reimbursement for PARP inhibitors remains a 'thorny issue'."

Reimbursement • Breast Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

Maha H.A. Hussain, MD, on Prostate Cancer: New Data on Abiraterone and Prednisone Plus Olaparib (THE ASCO POST) - "Maha H.A. Hussain, MD...discusses phase II findings from the BRCAAway trial. This study showed that in patients with metastatic castration-resistant prostate cancer with BRCA1/2 or ATM alterations, abiraterone and prednisone plus olaparib was well tolerated and resulted in a longer progression-free survival than either agent alone or sequentially."

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Johnson & Johnson Highlights Ambition to Transform the Treatment of Prostate Cancer and Bladder Cancer through Data Presentations at ASCO GU (PRNewswire) - "Johnson & Johnson announced today new clinical and real-world evidence data will be featured in 18 abstracts at this year's ASCO GU Symposium (San Francisco, January 25-27), highlighting the Company's commitment to transform the science of genitourinary (GU) cancers. Key presentations will include new real-world evidence data adding to the strong and differentiated clinical profile of ERLEADA (apalutamide) in the treatment of various stages of prostate cancer, patient-reported outcomes data from the Phase 3 MAGNITUDE study of niraparib plus abiraterone acetate given with prednisone, and updates on targeted releasing systems TAR-200 and TAR-210."

Clinical data • P3 data • Real-world • Bladder Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone (PRNewswire) - P3 | N=765 | MAGNITUDE (NCT03748641) |Sponsor: Janssen Research & Development, LLC | "The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis (FA) of the Phase 3 MAGNITUDE study, in which a pre-planned multivariate analysis [MVA] showed niraparib...combined with abiraterone acetate and given with prednisone, improved overall survival (OS) and time to symptomatic progression (TSP) and showed a favorable trend in time to cytotoxic chemotherapy (TCC) in patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA alterations....Patient-reported outcomes were also assessed in the FA. Results indicate that patients with BRCA mutations treated with niraparib and AAP experienced a trend towards delayed time to worst pain progression (HR 0.81; 95 percent CI, 0.52-1.25) and pain interference progression (HR 0.77; 95 percent CI, 0.48-1.23) compared with the placebo arm."

P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor