FDA approval for Janssen’s prostate cancer treatment

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega™ (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).

Akeega is the first-and-only orally administered, once daily dual action tablet of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, an androgen biosynthesis inhibitor.

The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study. In the randomised, double-blind, placebo-controlled trial BRCA-positive patients treated with the combination Akeega™ plus prednisone, showed a statistically significant 47 percent risk reduction for radiographic progression-free survival (rPFS) compared to those treated with abiraterone acetate plus prednisone (AAP).

“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,” stated Kiran Patel, MD and Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC.

Akeega received a marketing authorisation valid throughout the European Union on in April 2023, a year after it submitted the application to the European Medicines Agency. This followed a positive recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP) in February 2023.

Personalised approach to prostate cancer treatment

Prostate cancer is one of the most common cancers, with an estimated 288,300 new cases and nearly 35,000 deaths expected in the US in 2023, according to the American Cancer Society. Approximately 10 to 15 percent of patients with mCRPC have BRCA gene alterations, making them more likely to have aggressive disease.

“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 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.”

In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and licensing agreement with TESARO, Inc. (acquired by GlaxoSmithKline in 2019) for exclusive rights to niraparib in prostate cancer treatment.