JnJ gets USFDA priority review for Akeega plus prednisone for prostate cancer
Horsham: Johnson and Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the company for its supplemental New Drug Application (sNDA) for AKEEGA (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA-mutated metastatic castration-sensitive prostate cancer (mCSPC).
Patients with BRCA mutations have a poor prognosis, representing a significant unmet medical need not addressed by currently available therapies.
The sNDA is supported by data from the Phase 3 AMPLITUDE study, which demonstrated that treatment with AKEEGA plus prednisone reduced the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52; 95 percent confidence interval [CI], 0.37–0.72; p<0.0001) in patients with BRCA-mutated mCSPC. It also significantly prolonged the time to symptomatic progression by 56 percent (HR 0.44; 95 percent CI, 0.29–0.68; p=0.0001) and showed a trend toward improved overall survival (OS), with a 25 percent reduction in the risk of death (HR 0.75; 95 percent CI, 0.51–1.11; p=0.15).
If approved, AKEEGA plus prednisone would be the PARP-based precision medicine combination treatment for this patient population. Patients with BRCA-mutated mCSPC experience approximately 50 percent faster disease progression and shorter survival—highlighting the importance of early genetic testing to inform treatment decisions and the urgent need for novel targeted therapies to delay disease progression and improve outcomes for patients.
Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that has spread to other parts of the body but still responds to hormone therapy (androgen deprivation therapy). While the treatment landscape has advanced in recent years, almost all patients eventually develop resistance to therapy, and the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive and currently incurable disease stage. Approximately 25 percent of patients with mCSPC have HRR gene alterations, including BRCA, which have been shown to negatively impact outcomes. Patients with BRCA mutations have a poor prognosis, representing a significant unmet medical need not addressed by currently available therapies.
