By Fineline Cube The US Food & Drug Administration (FDA) has granted marketing approval to Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen for its oral drug Akeega (niraparib + abiraterone) in combination with prednisone. This treatment is designated for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The disease accounted for 288,300 new cases in the US last year, with an estimated 10% to 15% of these cases presenting mutations in the BRCA gene.
Clinical Data Supports Akeega’s Efficacy and Safety
The FDA’s decision is supported by clinical data demonstrating that the combination, including the PARP inhibitor niraparib, achieved a 47% risk reduction for radiographic progression-free survival (rPFS) in a BRCA-positive subgroup compared to abiraterone + prednisone. The safety profile of the combination was found to be consistent with that of each monotherapy, indicating a favorable risk-benefit ratio.
Akeega’s Global Approval Status
According to Fineline Info & Tech data, earlier this year, Akeega received approval for the same indication in Europe. This global recognition highlights the importance of Akeega as a treatment option for patients with BRCA-positive mCRPC and underscores Janssen’s commitment to addressing unmet medical needs in oncology.-Fineline Info & Tech