HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved an expanded indication for AKEEGA, clearing the first FDA-approved precision medicine combination for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer.
The approval covers AKEEGA, a dual-action tablet combining niraparib and abiraterone acetate, used with prednisone and androgen deprivation therapy. The decision positions the treatment as a new option for a patient population known to face faster disease progression and poorer outcomes than prostate cancer patients without BRCA mutations.
Regulatory clearance was based on results from the Phase 3 AMPLITUDE trial, a randomized, double-blind, placebo-controlled international study. In patients with BRCA2-mutated mCSPC, the combination reduced the risk of radiographic progression or death by 54 percent compared with the current standard of care. The therapy also delayed the onset of symptomatic disease progression by 59 percent.
Bradley McGregor, director of clinical research at the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, said the findings address a long-standing treatment gap. He said the trial was the first to demonstrate that pairing a PARP inhibitor with an androgen receptor pathway inhibitor can delay both radiographic and symptomatic progression in this high-risk group.
Johnson & Johnson said the safety profile observed in the study was consistent with what has been seen for the individual therapies. Common adverse reactions included fatigue, musculoskeletal pain, anemia, changes in blood cell counts, gastrointestinal effects, hypertension, and laboratory abnormalities.
Mahadi Baig, vice president and head of solid tumors for U.S. Medical Affairs at Johnson & Johnson Innovative Medicine, said the approval reflects the company’s focus on more personalized cancer treatments. He said AKEEGA is now the first and only PARP-based precision medicine combination approved for BRCA2-mutated mCSPC, offering patients a new approach aimed at delaying disease progression.
The company said patients prescribed AKEEGA can access support through its J&J withMe program, which provides education and cost assistance at no charge.
For investors, the approval strengthens Johnson & Johnson’s oncology portfolio and adds momentum to its precision medicine strategy, as demand grows for therapies tailored to specific genetic drivers of disease.
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