The CHMP committee at the EMA gave a positive opinion on the extension of the indication of Akeega (niraparib and abiraterone acetate in one tablet) from Johnson & Johnson.[1][2][3] The recommendation refers to the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations (germline or somatic) in combination with prednisone or prednisolone (AAP) and androgen deprivation (ADT).[3][4][6] The opinion is based on the results of the phase 3 AMPLITUDE trial, which included 696 patients with mHSPC and HRR gene alterations.[1][2][3] The study demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of radiographic progression-free survival (rPFS).[1][3][4] The niraparib/AAP combination delayed disease progression and showed an early trend of improved overall survival.[2][3] In patients with BRCA alterations, treatment increased time to symptomatic progression by 56 percent (HR 0.44, 95% CI 0.29-0.68, p=0.0001).[3] The safety profile is consistent with the already approved indication in mCRPC; most frequent serious adverse events 3./4. grade were anemia and hypertension, with a low number of treatment discontinuations.[1][3]