The U.S. FDA has expanded the indication for Johnson & Johnson’s (JNJ) Akeega (niraparib and abiraterone) to include BRCA2-mutated metastatic castration-sensitive prostate cancer.
The approval was based on results from the AMPLITUDE trial that showed statistically significant improvement in radiographic progression-free survival for those on Akeega plus prednisone compared to those on placebo and abiraterone.
Akeega was already approved for BRCA-mutated metastatic castration-resistant prostate cancer.
