Janssen Submits New Drug Application for Niraparib Combination in Metastatic, Gene-Altered Prostate Cancer


Niraparib with abiraterone acetate could be the first dual-action tablet for patients with metastatic castration-resistant prostate cancer and BRCA mutations.

Janssen has submitted a New Drug Application (NDA) to the FDA for a dual-action tablet (DAT)—niraparib with abiraterone acetate—plus prednisone to treat patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC), according to a recent press release. The NDA is supported by interim results from the MAGNITUDE study presented at the American Society of Clinical Oncology – Genitourinary Cancers Symposium (ASCO GU) 2022 and 2023 Annual Meetings.1

“Patients with mCRPC and BRCA mutations face a more aggressive form of prostate cancer and high unmet needs in terms of treatment options,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area head, Oncology, Janssen Research & Development, LLC. “The data supporting this submission reinforce the importance of biomarker testing to identify the subgroups of patients that are most likely to respond to a targeted treatment option.”1

The indication is only for patients with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alteration, who have not been treated with anything besides standard of care, next-generation androgen receptor inhibitors, or up to 4 months of abiraterone acetate plus prednisone (AAP).1

Niraparib is orally active poly-(ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate is an orally administered androgen biosynthesis inhibitor. If granted FDA approval, Janssen’s DAT could be the first approved for mCRPC patients with BRCA mutation.1

Investigators studied this therapeutic combination in the phase 3, randomized, double-blind, placebo-controlled, and multicenter MAGNITUDE study (NCT03748641). They evaluated niraparib combination for safety and efficacy as a first-line therapy in mCRPC patients with and without HHR alterations. Among those with HRR gene alteration, patients either received niraparib 200 mg once daily plus AAP or placebo plus AAP.1 The primary endpoint was radiographic progression-free survival (rPFS) in patients who are HRR-positive or have BRCA mutation.

Niraparib and AAP reduced risk of progression or death by 45% versus AAP alone.2 As it relates to secondary endpoints—time-to-initiation of cytotoxic chemotherapy (TCC), symptomatic progression (TSP), and overall survival (OS)— the combination prolonged TCC and TSP in HRR-positive and BRCA-mutated patients, whereas data on the latter have not been fully evaluated.1,2

Globally, prostate cancer is the second most common cancer in men. Among more than 1 million men who are diagnosed with prostate cancer each year, those with mCRPC—prostate cancer that has spread in the body (commonly bones, lungs, and liver) and does not respond to androgen deprivation therapy—and HRR gene alterations have the worst risk for aggressive disease, poor outcomes, and faster mortality.1

“This submission further represents our commitment at Janssen to discover and develop precision medicine approaches and combination therapies to help improve outcomes for patients living with genetically defined disease,” Lebowitz said in the press release.1


  1. Janssen. Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant P. March 1, 2023. News Release. Accessed on March 8, 2023. https://www.janssen.com/janssen-submits-new-drug-application-us-food-and-drug-administration-seeking-approval-niraparib-and
  2. Flaherty C. Updated MAGNITUDE Data Support Niraparib Combination in mCRPC and HRR Gene Alterations. Onc Live. March 8, 2023. Accessed March 8, 2023 https://www.onclive.com/view/updated-magnitude-data-support-niraparib-combination-in-mcrpc-and-hrr-gene-alterations
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