FDA Approves Akeega Plus Prednisone for BRCA-Positive Prostate Cancer Subset

The Food and Drug Administration (FDA) approved Akeega (niraparib and abiraterone acetate) with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer.

Akeega is the first dual-action tablet consisting of a PARP inhibitor and abiraterone acetate, according to a press release from Janssen, the manufacturer of the drug.

The FDA approval was based on findings from the phase 3 MAGNITUDE trial, which assessed Akeega plus prednisone in BRCA-positive metastatic castration-resistant prostate cancer. Akeega plus prednisone reduced the risk for radiographic progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) by 47%, according to the release.

After a median follow-up of 24.8 months, radiographic progression-free survival was 19.5 months in the Akeega plus prednisone group compared with 10.9 months in the placebo plus abiraterone acetate and prednisone group. Patients assigned Akeega plus prednisone also experienced improvements in time to symptomatic progression (the time before symptoms worsen) and the time to initiation of cytotoxic chemotherapy, both of which were driven by an improvement in overall survival (the time from treatment assignment when a patient with cancer is still alive).

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” Dr. Kim Chi, medical oncologist at BC Cancer – Vancouver and principal investigator of the phase 3 MAGNITUDE study, said in the 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 side effect profile of Akeega plus prednisone was consistent with previously study findings. In the MAGNITUDE trial, 41% of patients with a BRCA gene alteration experienced a serious side effect. In patients assigned Akeega or placebo plus prednisone, the most common side effects, which occurred in at least 20% of patients in the trial, included musculoskeletal pain (44% versus 42%, respectively), fatigue (43% versus 30%), high blood pressure (33% versus 27%), constipation (34% versus 20%) and nausea (33% versus 21%), according to the release. Fifteen percent of patients in the trial permanently discontinued any component of the Akeega regimen because of a side effect.

“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,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer, said in the release. “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.”

Dr. Kiran Patel, vice president of clinical development of solid tumors at Janssen Research and Development, added in the release: “This milestone, which makes 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 (metastatic castration-resistant prostate cancer).”

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