TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

FDA Clears AKEEGA™, a Novel Dual-Action Tablet with Niraparib and Abiraterone Acetate, for Treating Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Monday, August 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the U.S. Food & Drug Administration (FDA) granted approval to AKEEGA™ (niraparib and abiraterone acetate). This innovative dual-action tablet combines a PARP inhibitor with abiraterone acetate and is administered alongside prednisone. It is indicated for treating adult patients with confirmed or suspected deleterious BRCA-positive mCRPC, identified through an FDA-approved test.

Dr. Kim Chi, a Medical Oncologist at BC Cancer – Vancouver and the principal investigator of the Phase 3 MAGNITUDE study, emphasized the importance of identifying patients with a poor prognosis, especially those harboring a BRCA mutation. The MAGNITUDE study was strategically designed to pinpoint the subset of patients most likely to benefit from the targeted treatment with AKEEGA™, aiming to improve health outcomes for these individuals.

Prostate cancer is highly prevalent in the U.S., with an estimated 288,300 new cases and around 35,000 projected deaths in 2023. Roughly 10 to 15 percent of mCRPC patients carry BRCA gene alterations. These individuals generally face more aggressive disease, worse outcomes, and shorter survival times. The approval of AKEEGA™ introduces a crucial treatment option for prostate cancer patients and underscores the significance of genetic testing and precision medicine in managing this condition.

The FDA's approval is grounded in the positive results of the Phase 3 MAGNITUDE study, a randomized, double-blind, placebo-controlled trial. In patients with BRCA-positive status who were treated with AKEEGA™ plus prednisone, there was a statistically significant 47 percent reduction in the risk of radiographic progression-free survival (rPFS). Secondary endpoints such as time to symptomatic progression and time to initiation of cytotoxic chemotherapy also displayed improvements with AKEEGA™ plus prednisone.

Safety findings revealed that the combined therapy's safety profile aligned with the established safety profiles of individual monotherapies. Among patients with a BRCA gene alteration in the MAGNITUDE study, 41 percent experienced a serious adverse event while taking AKEEGA™. Common adverse events seen in 20 percent or more of patients taking AKEEGA™ plus prednisone included musculoskeletal pain, fatigue, constipation, hypertension, and nausea. Approximately 15 percent of patients discontinued any component of AKEEGA™ due to adverse reactions.

Dr. Kiran Patel, Vice President, Clinical Development, Solid Tumors, Jansen Research & Development, LLC, underscored the significance of this approval as a milestone in Janssen's contribution to advancing prostate cancer science. This achievement highlights the importance of precision medicine approaches and genetic testing for effectively treating patients diagnosed with BRCA-positive mCRPC.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit