FDA approves Janssen’s AKEEGA to treat prostate cancer

2023-08-14

临床结果临床3期上市批准

FDA approves Janssen’s AKEEGA to treat prostate cancer

Preview

来源: Pharmaceutical Technology

AKEEGA is intended for the treatment of metastatic castration-resistant prostate cancer. Credit: Chinnapong/Shutterstock.com.

The US Food and Drug Administration (FDA) has approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s AKEEGA for treating patients with metastatic castration-resistant prostate cancer (mCRPC).

A once-daily dual-action tablet, AKEEGA comprises a highly selective poly (ADP-ribose) polymerase inhibitor poly (ADP-ribose) polymerase inhibitor, niraparib, and an androgen biosynthesis inhibitor, abiraterone acetate.

Recommended Reports

Preview

来源: Pharmaceutical Technology

ReportsLOA and PTSR Model - Docetaxel in Prostate Cancer GlobalData

Preview

来源: Pharmaceutical Technology

ReportsLOA and PTSR Model - Tivozanib Hydrochloride in Prostate Cancer GlobalData

View allCompanies IntelligenceJanssen IncView all

It is indicated with prednisone to treat adults with mCRPC and BRCA[a specific cancer gene]-positive mutations.

AKEEGA is available in 200mg and 100mg niraparib/1,000mg abiraterone acetate dosages. The high dosage is the recommended starting dose while the low dosage is available for dose reduction.

The approval is based on positive results from the Phase III MAGNITUDE study that evaluated the combination therapy.

In the multi-centre, placebo-controlled, double-blind, randomised study, a statistically significant risk reduction of 47% was observed for radiographic progression-free survival (rPFS) in BRCA-positive patients.

The safety profile of the combined therapy was consistent with the known profile of each monotherapy approved by the FDA, with serious adverse events (AEs) reported in 41% of patients.

More than 20% of patients experienced the most common AEs: nausea, constipation, fatigue, hypertension and musculoskeletal pain. 15% permanently discontinued due to an adverse reaction.

Janssen research and development (solid tumours) clinical development vice-president Kiran Patel stated: “Janssen’s legacy of advancing the science of prostate cancer has contributed to the evolution of transformational treatment approaches for more than a decade.

“This milestone, which marks the approval of Janssen’s third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC.”

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构