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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.