Johnson & Johnson Receives CHMP Positive Opinion for AKEEGA in mHSPC with BRCA1/2 Mutations

Reuters01-30 23:09

Johnson & Johnson Receives CHMP Positive Opinion for AKEEGA in mHSPC with BRCA1/2 Mutations

Johnson & Johnson has received a positive opinion from the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency $(EMA)$ for an extension of the indication for AKEEGA® (niraparib and abiraterone acetate dual action tablet). The CHMP recommendation supports the use of niraparib and abiraterone acetate, in combination with prednisone or prednisolone and androgen deprivation therapy $(ADT)$, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who have BRCA1/2 mutations (germline and/or somatic). The recommendation is based on data from the AMPLITUDE study presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The extension is pending final approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief on January 30, 2026, and is solely responsible for the information contained therein.

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The CHMP recommendation supports the use of niraparib and abiraterone acetate, in combination with prednisone or prednisolone and androgen deprivation therapy $(ADT)$, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who have BRCA1/2 mutations (germline and/or somatic). The recommendation is based on data from the AMPLITUDE study presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The extension is pending final approval.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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