Niraparib and Abiraterone Acetate Nets European Approval in BRCA1/2-Mutated mHSPC

The European Commission (EC) has approved an indication extension for niraparib and abiraterone acetate dual-action tablets (Akeega), in combination with prednisone or prednisolone and androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) harboring germline and/or somatic BRCA1/2 mutations.¹

The regulatory decision was supported by data from the phase 3 AMPLITUDE trial (NCT04497844), which demonstrated that patients who received niraparib and abiraterone acetate in combination with prednisone (n = 191) achieved a median radiographic progression-free survival (rPFS) that was not estimable (NE; 95% CI, 41.2 months-NE) compared with 26 months (95% CI, 22.1-41.2) for those treated with placebo and abiraterone acetate (n = 196; HR, 0.52; 95% CI, 0.37-0.72; P < .0001).^1,2 Patients in the investigational arm also experienced a significant improvement in terms of time to symptomatic progression compared with those in the control arm(HR, 0.44; 95% CI, 0.29-0.68; P = .0001).

“Patients with BRCA-mutated metastatic prostate cancer often experience rapid progression on the current standard of care, highlighting a significant unmet need for more personalized treatment approaches that address the underlying biology of their disease,” Elena Castro, MD, PhD, a medical oncologist and group leader at Hospital Universitario 12 de Octubre in Madrid, Spain, stated in a news release.¹ “Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression.”

In December 2025, the FDA approved niraparib and abiraterone acetate in combination with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.³ The approval was also supported by data from AMPLITUDE.

How was AMPLITUDE designed?

AMPLITUDE was a randomized, double-blind, placebo-controlled, international, multicenter study that enrolled patients with deleterious germline or somatic homologous recombination repair (HRR) gene–altered mHSPC.¹ Patients also had to be at least 18 years of age and have an ECOG performance status of 2 or less.²

Eligible patients were randomly assigned 1:1 to receive a dual-action tablet of niraparib at 200 mg and abiraterone acetate at 1000 mg plus prednisone at 5 mg orally once daily or matched placebo and abiraterone acetate tablets plus prednisone continuously in 28-day cycles.

The primary end point was rPFS. Overall survival (OS) and time to symptomatic progression were assessed as key secondary end points.

What did the additional efficacy data and safety profile show?

Findings from the second interim analysis of AMPLITUDE demonstrated that patients in the investigational arm experienced a 20% reduction in the risk of death compared with the control arm (HR, 0.80; 95% CI, 0.58-1.11); follow-up is ongoing.¹ The respective objective response rates were 72% and 74% among patients in the investigational (n = 106) and control arms (n = 110) with measurable disease at baseline.² Patients in the investigational arm experienced a benefit in terms of duration of response (HR, 0.55; 95% CI, 0.35-0.86; nominal P = .008) and time to prostate-specific antigen progression (HR, 0.50; 95% CI, 0.39-0.65; nominal P < .0001) compared with those in the control arm.

Regarding safety, grade 3 or 4 adverse effects (AEs) occurred at a rate of 75.2% in the investigational arm (n = 347) compared with 58.9% in the control arm (n = 348). Serious AEs (39.2% vs 27.6%, respectively) and treatment discontinuations due to AEs (14.7% vs 10.3%) were reported in both arms.

“This expanded indication for niraparib and abiraterone acetate reflects our commitment to delivering transformative innovation across the prostate cancer continuum,” Charles Drake, MD, PhD, FAAP, vice president and leader of the Prostate Cancer and Immunotherapy Disease Area at Johnson & Johnson, added in the news release.¹ “Niraparib and abiraterone acetate is the first precision-medicine combination treatment approved for patients with BRCA1/2-mutated mHSPC and is supported by strong clinical data demonstrating a clinically meaningful delay in disease progression.”

References

1. European Commission approves Akeega (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC). News release. Johnson & Johnson. March 9, 2026. Accessed March 10, 2026. https://www.jnj.com/media-center/press-releases/european-commission-approves-akeega-niraparib-and-abiraterone-acetate-dual-action-tablet-for-the-treatment-of-patients-with-brca1-2-mutated-metastatic-hormone-sensitive-prostate-cancer-mhspc
2. Attard G, Agarwal N, Graff JN, et al. Niraparib and abiraterone acetate plus prednisone for HRR-deficient metastatic castration-sensitive prostate cancer: a randomized phase 3 trial. Nat Med. 2025;31(12):4109-4118. doi:10.1038/s41591-025-03961-8
3. FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. FDA. December 12, 2025. Accessed March 10, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration