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Medical Professionals Reference (MPR)Akeega, an Oral Combo Therapy for BRCA-Mutated mCRPC, Gets FDA Approval

Niraparib, a PARP inhibitor, and abiraterone acetate, a CYP17 inhibitor, are combined in one tablet under the brand name Akeega.

The FDA has given its approval to Akeega, a novel oral therapy for adult patients with specific BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). This combination therapy, which includes a PARP inhibitor and a CYP17 inhibitor, has shown significant improvement in radiographic progression-free survival (rPFS) in a phase 3 study, offering a new treatment option for this patient population.

Key Points:

  • Akeega combines niraparib and abiraterone acetate into a single tablet.
  • Approval based on the MAGNITUDE study.
  • Statistically significant improvement in rPFS in the BRCAm subgroup (HR, 0.53 [95% CI, 0.36-0.79]; P =.0014).
  • Median OS in the BRCAm subgroup: 30.4 months for niraparib plus abiraterone, 28.6 months for placebo plus abiraterone.
  • Most common adverse reactions include decreased hemoglobin, lymphocytes, white blood cells, and increased alkaline phosphatase.

Additional Points:

  • In the overall HRR population, the rPFS HR was 0.73 (95% CI, 0.56-0.96; P =.0217).
  • 27% of patients in the study required a red blood cell transfusion.
  • Akeega is supplied in 2 dosage strengths: niraparib 50mg/abiraterone acetate 500mg and niraparib 100mg/abiraterone acetate 500mg.
  • FDA approved FoundationOne®CDx as a companion diagnostic for Akeega.


  • Akeega’s approval provides a targeted treatment option for patients with BRCA-mutated mCRPC, backed by promising clinical data and a manageable safety profile.

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“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation. We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with Akeega and to help us understand how we can potentially achieve better health outcomes for patients.”

Kim Chi, MD
Medical Oncologist at BC Cancer – Vancouver
Principal Investigator of the Phase 3 MAGNITUDE Study
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