FDA approves dual action tablet for BRCA-positive prostate cancer

Prostate cancer cells

Janssen’s Akeega (niraparib and abiraterone acetate) is now available in the US for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) following FDA approval.

It is the first dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, to be approved in this indication.

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” said Kim Chi, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase III MAGNITUDE study. “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.”

The European Commission (EC) granted marketing authorisation for Akeega in April 2023.

Approximately 10-15% of patients with mCRPC have BRCA gene alterations. Patients with BRCA-positive mCRPC are more likely to have aggressive disease and may experience poor outcomes and a shorter survival time.

The FDA approval is based on results from the Phase III MAGNITUDE study, which showed a statistically significant 47% risk reduction for radiographic progression-free survival (rPFS).

With median follow-up at 24.8 months in the BRCA-positive subgroup, rPFS by central review demonstrated a consistent trend favouring Akeega plus prednisone, with a median rPFS of 19.5 months compared with 10.9 months for placebo and abiraterone acetate plus prednisone (AAP).

There was also an observed improvement in the secondary endpoints of time to symptomatic progression (TSP) and time to initiation of cytotoxic chemotherapy (TCC) for Akeega plus prednisone compared with AAP alone.

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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