By Fineline Cube 
Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for an expanded indication of AKEEGA (niraparib‑abiraterone) in combination with prednisone/prednisolone (AAP) and androgen deprivation therapy (ADT) for patients with BRCA1/2 mutations (germline and/or somatic) in metastatic hormone‑sensitive prostate cancer (mHSPC).
Regulatory Milestone & Clinical Basis
| Item | Detail |
|---|---|
| Company | Johnson & Johnson (NYSE: JNJ) |
| Drug | AKEEGA (niraparib‑abiraterone) |
| Combination | Prednisone/prednisolone (AAP) + Androgen deprivation therapy (ADT) |
| Indication | mHSPC with BRCA1/2 mutations (germline/somatic) |
| Regulatory Body | CHMP of EMA |
| Recommendation | Positive opinion for expanded indication |
| Clinical Basis | AMPLITUDE study |
AMPLITUDE Study Key Efficacy Data
| Endpoint | Niraparib/AAP Group | Control Group | Result |
|---|---|---|---|
| Radiographic PFS (rPFS) | Not reached | 26 months | Risk reduction 48% (P < 0.0001) |
| Time to Disease Progression | — | — | Extended by 56% (P < 0.0001) |
| Overall Survival (OS) | Early trend | — | Death risk reduced 25% (data immature, follow‑up ongoing) |
Safety Profile
- Consistency: Safety profile in mHSPC consistent with approved mCRPC indication
- Most Common Grade 3/4 AEs: Anemia and hypertension
- Discontinuation Rate: Low discontinuation due to adverse events
- Manageability: AEs manageable through dose adjustments and supportive care
Market Impact & Commercial Outlook
- Prostate Cancer Market: EU mHSPC market valued at $1.2 billion : 2025; BRCA‑mutated subset represents ~10–15% : of patients
- Competitive Advantage: First PARP inhibitor + AR pathway combination in BRCA‑mutated mHSPC; differentiates from standard AR‑targeted therapy alone
- Revenue Potential: Analysts project €300–500 million : peak annual EU sales for AKEEGA in expanded indication by 2028
- Strategic Value: Strengthens J&J’s prostate cancer franchise following Erleada success; validates combination approach in earlier disease stage
- Next Steps: European Commission decision expected Q2 2026; potential US FDA filing under evaluation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approval timelines, commercial expectations, and revenue projections for AKEEGA. Actual results may differ due to EC review outcomes, competitive dynamics, and market access negotiations.-Fineline Info & Tech