- CHMP recommends AKEEGA® for mHSPC with BRCA1/2 mutations.
- Phase 3 AMPLITUDE study shows 48% reduced risk of progression or death.
- Median rPFS not reached vs. 26 months for placebo group.
- Common Grade 3/4 adverse events include anemia and hypertension.
CHMP Recommendation
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended an indication extension for AKEEGA® (niraparib and abiraterone acetate) for treating metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations.
AMPLITUDE Study Results
The Phase 3 AMPLITUDE study evaluated the efficacy and safety of the niraparib/AAP combination in 696 patients with mHSPC and homologous recombination repair gene alterations. The study showed a 48% reduction in the risk of radiographic progression or death compared to placebo, with the median radiographic progression-free survival (rPFS) not reached in the treatment group versus 26 months in the placebo group.
Safety Profile
The safety profile of the niraparib/AAP combination was consistent with previous findings in metastatic castration-resistant prostate cancer. Common Grade 3/4 adverse events included anemia and hypertension, but treatment discontinuations due to adverse events were low and manageable with dose modifications and supportive care.
Implications for Treatment
Patients with mHSPC and BRCA1/2 mutations face aggressive disease with limited treatment options. The niraparib and abiraterone acetate dual action tablet offers a targeted treatment strategy, addressing an urgent medical need before the disease progresses to a more resistant stage.
