FDA approved Janssen’s Akeega for prostate cancer treatment
The Janssen Pharmaceutical companies of Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Akeega (niraparib and abiraterone acetate) for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).
The drug is the first and only dual action tablet to combine a PARP inhibitor with abiraterone acetate, given with prednisone, to treat this indication.
This approval follows positive results from the randomised, double-blind, placebo-controlled, multi-centre phase 3 MAGNITUDE study, which assessed the use of Akeega in combination with prednisone for the treatment of patients with BRCA-positive mCRPC. The drug showed a statistically significant rate of progression-free survival, as well as an improvement in time to symptomatic progression, and a trend towards an improvement in overall survival.
Kim Chi, MD, medical oncologist at BC Cancer, Canada, and principal investigator on the phase 3 MAGNITUDE study, commented: “As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation. We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with Akeega and to help us understand how we can potentially achieve better health outcomes for patients.”
Shelby Moneer, MS CHES, vice president of Patient Programs and Education at ZERO Prostate Cancer, added: “The approval of Akeega brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease. All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes. This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes.”
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