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.

Conclusion:

• 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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