The U.S. FDA has approved J&J's Akeega, the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).
The approval, given to J&J's Janssen unit, is based on the phase 3 MAGNITUDE study, a prospectively designed precision medicine study including the largest population of BRCA-positive patients in combination trials to date with mCRPC. In patients treated with the combination Akeega (niraparib and abiraterone acetate) plus prednisone, a statistically significant 47% risk reduction was observed for radiographic progression-free survival.
Akeega was granted marketing authorization in the EU back in April, based on the same study.
Approximately 10-15% of patients with mCRPC have BRCA gene alterations, and these patients are more likely to have aggressive disease, poor outcomes and a shorter survival time.
Janssen entered a worldwide (ex-Japan) collaboration and license agreement with cancer biotech Tesaro for exclusive rights to niraparib in prostate cancer back in 2016. Tesaro was then acquired by GSK in 2019 in a $5.1 billion deal.
The Akeega approval is the second oncology win for Janssen in the past week. Just last week, the FDA granted accelerated approval to Talvey, a first-in-class novel bispecific antibody for heavily treated refractory multiple myeloma.