The FDA approval is based on the Phase 3 MAGNITUDE study, in which Akeega plus prednisone significantly improved radiographic progression-free survival compared to abiraterone acetate plus prednisone (AAP)
FDA approves Akeega to treat BRCA-positive mCRPC. (Credit: James Yarema on Unsplash)
The Janssen Pharmaceutical Companies of Johnson & Johnson has received the US Food & Drug Administration (FDA) approval for Akeega (niraparib and abiraterone acetate) to treat a type of Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Akeega is an oral, once-daily dual-action tablet (DAT) that contains a highly selective PARP inhibitor niraparib, and abiraterone acetate, an androgen biosynthesis inhibitor.
The drug is indicated for treating adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.
Akeega is recommended at a starting dose of 200mg niraparib/1,000mg abiraterone acetate, with 100mg niraparib/1,000mg abiraterone acetate as a dose reduction option.
In April 2016, Janssen Biotech signed a global collaboration and license agreement with TESARO to acquire exclusive rights to niraparib in prostate cancer.
Janssen Research and Development solid tumours clinical development vice president Kiran Patel said: “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.”
The FDA approval is based on positive results from MAGNITUDE, a randomised, double-blind, placebo-controlled multi-centre Phase 3 study in BRCA-positive patients.
In the Phase 3 study, patients treated with Akeega, in combination with prednisone showed a statistically significant 47% risk reduction for radiographic progression-free survival (rPFS).
Akeega plus prednisone showed a consistent trend with a median rPFS of 19.5 months compared with 10.9 months for placebo and AAP, at 24.8 months.
In addition, the combination improved the time to symptomatic progression (TSP) and time to initiation of cytotoxic chemotherapy (TCC) compared to AAP alone.
The improvement in TSP and TCC is supported by a trend towards improvement in overall survival (OS), which constitute the secondary endpoints.
Akeega plus prednisone combination showed a safety profile that was consistent with the known safety profile of each FDA-approved monotherapy.
The most common adverse events include musculoskeletal pain, fatigue, constipation, hypertension and nausea, said the US drugmaker.
Phase 3 MAGNITUDE study principal investigator Kim Chi said: “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.”