Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the expanded use of AKEEGA® (a dual-action tablet of niraparib and abiraterone acetate). The recommendation covers the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) who harbor BRCA1/2 mutations.
If approved by the European Commission, the niraparib-based combination administered alongside prednisone or prednisolone and androgen deprivation therapy (ADT) would become a new targeted standard of care for this specific patient population.
Addressing an Aggressive Form of Disease
Metastatic hormone-sensitive prostate cancer (mHSPC) is a stage where the cancer has spread beyond the prostate but still responds to hormone therapy. However, approximately 25% of these patients possess homologous recombination repair (HRR) gene alterations, with BRCA1/2 being the most common.
Patients with these mutations typically face a much bleaker prognosis, characterized by more aggressive disease progression and shorter overall survival compared to those without the mutations. Current standard treatments for mHSPC are generally not biomarker-selected, leaving a significant gap in personalized care for high-risk individuals.
Breakthrough Results from the AMPLITUDE Study
The CHMP’s positive opinion is rooted in data from the landmark Phase 3 AMPLITUDE study, which evaluated 696 patients across 32 countries. The trial compared the Akeega combination against a standard regimen of placebo plus abiraterone acetate and prednisone (AAP).
Key findings from the study included:
- Delayed Progression: In patients with BRCA1/2 mutations, the median radiographic progression-free survival (rPFS) was not yet reached for the Akeega group, compared to 26 months in the control group.
- Risk Reduction: The treatment reduced the risk of radiographic progression or death by 48% (HR 0.52).
- Symptomatic Relief: The combination prolonged the time to symptomatic progression by 56%.
- Survival Trends: While data is still maturing, interim analysis showed a 25% reduction in the risk of death (HR 0.75), indicating a positive trend toward improved overall survival.
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Safety and Integration into Care
The safety profile observed in the AMPLITUDE trial remained consistent with previous studies of Akeega in later-stage castration-resistant prostate cancer (mCRPC). The most frequent Grade 3/4 adverse events were anemia and hypertension, which were generally manageable through dose adjustments and standard supportive care.
About Akeega®
Akeega is a first-of-its-kind dual-action tablet (DAT) that combines niraparib, a PARP inhibitor, with abiraterone acetate, a CYP17 inhibitor. By targeting two different pathways DNA repair and androgen signaling the therapy aims to more effectively inhibit cancer cell growth in patients with specific genetic vulnerabilities.
Akeega was previously authorized in the European Union in April 2023 for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). This latest recommendation seeks to bring that same targeted efficacy to patients earlier in their diagnosis, potentially altering the long-term trajectory of the disease.
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