FDA Approves Johnson & Johnson's AKEEGA For BRCA2-Mutated Prostate Cancer

(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration has approved its supplemental New Drug Application (sNDA) for AKEEGA—a dual-action tablet combining niraparib and abiraterone acetate—administered with prednisone. This new treatment is indicated for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

BRCA mutations are associated with more aggressive forms of prostate cancer and poorer outcomes. The approval of AKEEGA addresses a critical unmet need, offering a new therapeutic option for patients who previously had limited treatment alternatives.

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

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