The U.S. Food and Drug Administration recently approved a new dual-action tablet for aggressive prostate cancer precision therapy. Johnson & Johnson’s dual-action tablet, AKEEGA, which combines niraparib and abiraterone acetate, is now authorized for use with prednisone to treat patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

Historically, the diagnosis for patients with BRCA mutations has been heavy. These genetic markers are often associated with highly aggressive forms of prostate cancer. As a result, it leads to a much faster decline and an overall poor prognosis. Before this precision treatment was approved, many patients faced an “unmet need” because traditional therapies had often struggled to keep up with the mutation’s progression.

Redefining the Standard of Care of Prostate Cancer

prostate cancer
Photo: Julien Tromeur/Shutterstock

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In patients with the BRCA2 mutation, the treatment reduced the risk of death or the cancer spreading (radiographic progression) by 54%. Additionally, it extended the time patients lived without worsening symptoms by 59%.

“There remains an urgent need for novel therapies for patients with BRCA2-mutated mCSPC, who face significantly faster disease progression and often shorter survival compared to those without the mutation,” said Dr. Bradley McGregor of the Dana-Farber Cancer Institute. “AMPLITUDE is the first study to show that this precision medicine combination… delays both radiographic and symptomatic disease progression.”

Scientists emphasized that the primary benefit of the system is its efficiency. A PARP inhibitor is combined with an androgen receptor pathway inhibitor into a single tablet. As a result, the therapy targets the cancer’s ability to repair its DNA while blocking the hormones that tumors need to grow.

“AKEEGA is now the first and only PARP-based precision medicine combination treatment in BRCA2-mutated mCSPC, offering patients hope for more time with a new way to potentially delay their cancer from progressing,” Mahadi Baig, M.D., Vice President at Johnson & Johnson Innovative Medicine, added.