{"id":68636,"date":"2026-06-22T14:22:06","date_gmt":"2026-06-22T06:22:06","guid":{"rendered":"https:\/\/flcube.com\/?p=68636"},"modified":"2026-06-22T14:22:07","modified_gmt":"2026-06-22T06:22:07","slug":"johnson-johnson-secures-second-nmpa-approval-for-akeega-in-brca2-mutated-metastatic-prostate-cancer-following-amplitude-trial-success","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68636","title":{"rendered":"Johnson & Johnson Secures Second NMPA Approval for Akeega in BRCA2-Mutated Metastatic Prostate Cancer Following AMPLITUDE Trial Success"},"content":{"rendered":"\n

Johnson & Johnson<\/strong> (J&J, NYSE: JNJ<\/a>) announced that China’s National Medical Products Administration (NMPA)<\/strong> has granted a second indication approval for Akeega<\/strong> (niraparib and abiraterone acetate) in combination with prednisone or prednisolone<\/strong> for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC)<\/strong> harboring germline and\/or somatic BRCA2 gene mutations<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>Akeega (niraparib + abiraterone acetate) + prednisone\/prednisolone<\/td><\/tr>
Indication<\/strong><\/td>mHSPC with BRCA2 mutations (germline\/somatic)<\/td><\/tr>
Approval Basis<\/strong><\/td>AMPLITUDE Phase III clinical trial<\/td><\/tr>
Previous Approval<\/strong><\/td>October 2024 for mCRPC with BRCA mutations<\/td><\/tr>
Therapy Regimen<\/strong><\/td>Akeega + prednisone + androgen deprivation therapy (ADT)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 AMPLITUDE Phase III Trial<\/h2>\n\n\n\n
Endpoint<\/th>Result (Akeega + ADT)<\/th>Comparator (Standard of Care + ADT)<\/th>Benefit<\/th><\/tr><\/thead>
Radiographic Progression-Free Survival (rPFS)<\/strong><\/td>Median not reached vs. 15.3 months<\/td>Standard of care + ADT<\/td>54% risk reduction<\/strong> (HR=0.46; 95% CI: 0.32\u20130.66)<\/td><\/tr>
Time to Symptomatic Progression (TSP)<\/strong><\/td>Significantly delayed<\/td>Standard of care + ADT<\/td>59% risk reduction<\/strong> (HR=0.41; 95% CI: 0.29\u20130.65)<\/td><\/tr>
Safety Profile<\/strong><\/td>Consistent with mCRPC experience<\/td>\u2013<\/td>No new safety signals identified<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The AMPLITUDE trial demonstrated unprecedented efficacy in the biomarker-selected mHSPC population, establishing Akeega as a potential new standard of care for patients with BRCA2-mutated disease.<\/p>\n\n\n\n

Strategic Market Impact<\/h2>\n\n\n\n