EU agency recommends expanded approval of niraparib/abiraterone dual tablet in mHSPC

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an expanded indication for niraparib and abiraterone acetate dual action tablet (Akeega) for use with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations.¹

The tablet was previously approved by the FDA in December 2025 for adult patients with deleterious or suspected deleterious BRCA2-mutated mHSPC.²

"Patients with metastatic hormone-sensitive prostate cancer who carry BRCA1/2 mutations face a more aggressive disease with survival outcomes that are significantly shorter, compared to those without these mutations, with limited treatment options before their disease progresses to metastatic castration-resistant prostate cancer," explained Henar Hevia, PhD, Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine, in a news release from the company.¹ "Pending approval, the niraparib and abiraterone acetate dual action tablet will offer a targeted treatment strategy with the potential to address this urgent medical need earlier in the metastatic pathway, before the disease becomes more resistant."

The recommendation is supported by findings from the phase 3 AMPLITUDE trial (NCT04497844), which showed that the combination of niraparib/AAP significantly improved radiographic progression-free survival (rPFS) compared with placebo plus AAP in patients with mHSPC harboring homologous recombination repair (HRR) gene alterations. The greatest treatment benefit was observed among patients with BRCA1/2 mutations. 

In total, the trial enrolled 696 patients who were randomly assigned 1:1 to receive abiraterone plus AAP (n = 348) or placebo plus AAP (n = 348).

In patients with BRCA1/2 mutations (n = 191), those who received niraparib/AAP demonstrated a 48% reduction in the risk of radiographic progression or death compared with those who received placebo/AAP (HR, 0.52; 95% CI, 0.37 to 0.72; P < .0001). The median rPFS was not estimable in the niraparib/AAP arm vs 26 months in the placebo/AAP arm.

The niraparib combination also significantly prolonged the time to symptomatic progression compared with placebo/AAP (HR 0.44; 95% CI, 0.29 to 0.68; P = .0001) in patients with BRCA alterations. Further, at the first interim analysis of the data, there was a trend toward improvement in overall survival favoring the niraparib/AAP arm (HR, 0.75; 95% CI, 0.51 to 1.11; P = .15).

In the overall trial population, grade 3 or 4 adverse events (AEs) occurred in 75% of patients in the niraparib plus AAP arm vs 59% of patients in the placebo plus AAP arm. The most frequent grade 3 or 4 AEs in the niraparib/AAP arm were anemia (29%) and hypertension (27%). Treatment-emergent AEs leading to death occurred in 14 patients in the niraparib plus AAP group vs 7 patients in the placebo plus AAP group.

Follow-up is ongoing in the AMPLITUDE study.

“Building on our deep legacy spanning nearly 2 decades in the treatment of prostate cancer, we are driven by the belief that the next frontier of care requires more personalized treatment approaches that address the specific drivers of high-risk disease,” concluded Charles Drake, MD, PhD, FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, Johnson & Johnson Innovative Medicine, in the news release.¹ “The combination of niraparib and abiraterone acetate represents an important step towards integrating targeted precision medicine into routine care, complementing our established apalutamide plus ADT option, a proven standard of care for the broader mHSPC patient population, reinforcing our commitment to delivering solutions across the prostate cancer continuum.”

REFERENCES

1. Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations. News release. Janssen Cilag International NV. January 30, 2026. Accessed February 3, 2026. https://www.globenewswire.com/news-release/2026/01/30/3229458/0/en/Johnson-Johnson-receives-CHMP-positive-opinion-for-AKEEGA-niraparib-and-abiraterone-acetate-dual-action-tablet-for-the-treatment-of-patients-with-metastatic-hormone-sensitive-prost.html

2. FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. News release. US Food & Drug Administration. December 12, 2025. Accessed December 12, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration

3. 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. doi:10.1038/s41591-025-03961-8