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

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."

Video

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

Janssen's prostate cancer drug Akeega arrives in Korea (Korea Biomedical Review) - "Janssen...has introduced Akeega, a prostate cancer therapy combining the existing abiraterone and PARP inhibitor niraparib, in Korea. On Monday, the Ministry of Food and Drug Safety (MFDS) approved Akeega as a combination therapy with prednisolone in treating adult patients who have not received chemotherapy after diagnosis of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC)....The rapid approval has become possible by Korea's significant participation in the pivotal phase 3 MAGNITUDE study."

Non-US regulatory • Prostate Cancer

AKEEGA (niraparib and abiraterone acetate) Now Available from Onco360 (Businesswire) - "Onco360...has been selected as a pharmacy partner by The Janssen Pharmaceutical Companies of Johnson & Johnson for AKEEGA™ (niraparib and abiraterone acetate). AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor, indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Niraparib (NIRA) with abiraterone acetate and prednisone (AAP) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: Second interim analysis (IA2) of MAGNITUDE (DGU 2023) - No abstract available.

Clinical

Niraparib/abiraterone acetate (Akeega) for prostate cancer. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

U.S. Food and Drug Administration (FDA) Approves FoundationOne CDx as a Companion Diagnostic for Janssen’s AKEEGA (niraparib and abiraterone acetate Dual Action Tablet) 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^® CDx to be used as a companion diagnostic for Janssen Biotech, Inc. (Janssen’s) AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)."

FDA event • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

FDA approves niraparib/abiraterone tablet for BRCA-positive mCRPC (Urology Times) - "'We all acknowledge that patients with metastatic CRPC and HRR alterations, especially BRCA [alterations], have a grim prognosis,' Efstathiou...said during her presentation."

Media quote • Regulatory

U.S. FDA Approves AKEEGA (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer (PRNewswire) - "The Janssen Pharmaceutical Companies of Johnson & Johnson...announced that the U.S. Food & Drug Administration (FDA) has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test....The FDA approval is based on positive results from the randomized, double-blind, placebo-controlled multi-center Phase 3 MAGNITUDE study. In BRCA-positive patients treated with the combination AKEEGA™ plus prednisone, a statistically significant 47 percent risk reduction was observed for radiographic progression-free survival (rPFS) (Hazard ratio [HR], 0.53; p=0.001)."

NDA • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CJNJ-67652000 and Prednisone for the Treatment of Men With Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

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

Health Canada Authorizes AKEEGA (niraparib and abiraterone acetate) Dual Action Tablets for Targeted Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with BRCA (1/2) Gene Mutations (Canada Newswire) - "The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance with conditions (NOC/c) for AKEEGA™ (niraparib and abiraterone acetate) tablets, plus prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom chemotherapy is not clinically indicated. Patients must have confirmation of BRCA mutation before AKEEGA™ treatment is initiated....The Health Canada NOC/c is based on positive results from the randomized, double-blind, placebo-controlled multicenter Phase 3 MAGNITUDE study."

Canadian regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2