AKEEGA

AKEEGA is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. It is also indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).

In the All HRR population, the median radiographic progression-free survival (rPFS) for the niraparib + AAP arm was 51.6 months, compared to 33 months for the AAP arm, with a hazard ratio of 0.64. For overall survival (OS) in the All HRR population, the median for the niraparib + AAP arm was 70.7 months versus 53 months for the AAP arm, with a hazard ratio of 0.75. In the BRCA mutation subgroup, the median rPFS for the niraparib + AAP arm was 60 months, compared to 33 months for the AAP arm, with a hazard ratio of 0.55. The trial was a Phase 3 study with 696 men enrolled.

Safety findings indicate that 4.6% (16 participants) in the niraparib + AAP arm received wrong treatment or incorrect dose, while 1.4% (5 participants) in the PBO + AAP arm experienced this. Additionally, 1.1% (4 participants) in the niraparib + AAP arm entered without meeting eligibility criteria, compared to 3.2% (11 participants) in the PBO + AAP arm. Regulatory scientific advice dates include 26 July 2018, 27 February 2020, and 20 May 2021.