Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

Sponsor: Janssen Research & Development, LLC

Expanded Access
Approved for Marketing
Sponsor score: 60

ClinicalTrials ID:NCT05401214

This pre-approval access program provides the Nira/AA combination for patients with mCRPC and HRR gene alterations. Eligible participants must have an ECOG PS of 0 or 1 and agree to take prednisone/prednisolone and a GnRH analogue if not surgically castrated. The intervention involves oral administration of Nira 100 mg and AA 500 mg tablets.

Patient Parameters

Program Overview

The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
  • A confirmed homologous recombination repair (HRR) gene alteration as identified by a genomic assay through use of a validated test
  • Eastern Cooperative Oncology Group Performance Score (ECOG PS) Grade of 0 or 1
  • Willing to receive concomitant prednisone/ prednisolone 10 milligrams (mg) (not provided by Janssen) daily while receiving niraparib/abiraterone acetate (Nira/AA) combination treatment
  • Willing to continue treatment with gonadotropin-releasing hormone (GnRH) analogue if not surgically castrated

Exclusion Criteria

  • Prior treatment with a Poly ADP-ribose Polymerase (PARP) inhibitor
  • Prior systemic therapy for mCRPC (that is, taxane-based chemotherapy, androgen signaling inhibitors). Ongoing androgen deprivation therapy (ADT), prior systemic treatment (example, apalutamide, enzalutamide, darolutamide, docetaxel) for earlier disease settings (example, hormone sensitive disease, non-metastatic castration-resistant disease); and treatment recently initiated with abiraterone acetate for mCRPC less than or equal to (<=) 60 days is permitted
  • Other treatment options available or participant eligible or able to participate in a clinical trial for first line mCRPC with HRR gene alterations
  • Moderate-severe pain
  • History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

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