FDA Approves Combination Tablet for Metastatic Prostate Cancer

The FDA has approved Janssen’s Akeega (niraparib and abiraterone acetate) tablet to treat patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). This is the first dual-action tablet formulation for these patients.

Metastatic castration-resistant prostate cancer is a cancer that has progressed despite medical or surgical treatment to lower testosterone. The most common metastatic sites are bones, followed by lungs and liver. About 10% to 50% of patients progress to mCRPC within three years of diagnosis, of which an estimated 10% to 15% harbor a BRCA mutation. Patients with mCRPC and HRR gene alterations are more likely to have aggressive disease, poor outcomes and a shorter survival time.

The combination of niraparib, a PARP inhibitor, and abiraterone acetate, a prodrug of abiraterone, a CYP17 inhibitor, targets two oncogenic drivers in patients with mCRPC: the androgen receptor axis and HRR gene alterations. It will be available in mid-September and have a list price of $18,750 for a 30-day supply, which a Janssen spokesperson said is comparable with other mCRPC PARP plus abiraterone therapies. The spokesperson also said they expect Akeega to be covered by a majority of Medicare and most commercial insurance plans. Janssen also offers access and support for qualifying patients.

Kim Chi, M.D.

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” Kim Chi, M.D., medical oncologist at BC Cancer – Vancouver and principal investigator of the phase 3 MAGNITUDE study, said in a press release. “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 approval is based on data from the MAGNITUDE study, which showed that Akeega demonstrated a 47% risk reduction in radiographic progression-free survival (rPFS). At the second interim analysis, with median follow-up at 24.8 months in the BRCA-positive subgroup, Akeega plus prednisone resulted a median radiographic progression-free survival of 19.5 months compared with 10.9 months for placebo.

The most common adverse events occurring in 20% or more of patients who received Akeega were musculoskeletal pain, fatigue, constipation, hypertension and nausea. Discontinuation of Akeega because of an adverse reaction occurred in 15% of patients.