FDA approves Akeega for mCRPC

On Friday, the US Food and Drug Administration (FDA) approved Akeega, the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.

The combo treatment was developed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Biotech and Akeega was granted priority review by the agency. The decision also marks the second FDA oncology approval for Janssen this week, following that of Talvey (talquetamab-tvgs).

In April this year, the European Medicines Agency (EMA) granted the first-ever approval for Akeega, for the same indication of mCRPC. While the EU nod broke new ground for the combination PARP inhibitor and anti-androgen therapy, the limitation to BRCA-positive cancer entails a smaller patient population than J&J had hoped for.