Johnson & Johnson’s Akeega Earns FDA Clearance

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Janssen Pharmaceutical, a Johnson & Johnson company, has officially received the FDA’s nod of approval for Akeega, the first dual action tablet with a poly-ADP ribose polymerase (PARP) inhibitor with abiraterone acetate. Indicated for the treatment of deleterious or suspected deleterious BRCA-positive metastatic castration resistant prostate cancer (mCRPC), approval was based on positive results from the randomized, double-blind, placebo-controlled multi-center phase three magnitude study.

“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, MS, CHES, vice president, patient programs, education, Zero Prostate Cancer. “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.”

Reference: U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer. Johnson & Johnson. August 11, 2023. Accessed August 15, 2023. https://www.jnj.com/u-s-fda-approves-akeega-niraparib-and-abiraterone-acetate-the-first-and-only-dual-action-tablet-for-the-treatment-of-patients-with-brca-positive-metastatic-castration-resistant-prostate-cancer