FDA Approves J&J’s Akeega for Expanded Use in Prostate Cancer
Johnson & Johnson JNJ announced that the FDA approved its precision therapy, Akeega (niraparib and abiraterone acetate dual-action tablet), for a second indication in prostate cancer. The agency has cleared this drug, in combination with prednisone, to treat patients with BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC).
Per J&J, this label expansion marks the first FDA-approved precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor for BRCA2m mCSPC. The approval is supported by data from the phase III AMPLITUDE study, which showed that treatment with the Akeega-prednisone combo reduced the risk of radiographic progression or death by 54%.
With this new indication, the drug’s use has been expanded to an earlier stage of the disease. The FDA approved the combination of Akeega and prednisone in 2023 to treat BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
Akeega combines the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate. While niraparib is an active ingredient used in GSK plc’s GSK cancer drug Zejula, abiraterone acetate is marketed by J&J under the brand name Zytiga for prostate cancer. The company has an exclusive agreement with GSK for the rights to niraparib in prostate cancer.
