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, niraparib, and an androgen biosynthesis inhibitor, abiraterone acetate.

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.

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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.”