On Friday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson's (NYSE:JNJ) supplemental New Drug Application (sNDA) for Akeega (niraparib and abiraterone acetate) plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

Patients with BRCA mutations often have more aggressive forms of prostate cancer.

The approval is based on results from the AMPLITUDE Phase 3 clinical study.

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Data

Treatment with Akeega plus prednisone and androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 54% compared to placebo/abiraterone acetate plus prednisone and ADT, which is the current standard of care.

Akeega plus prednisone and ADT also significantly prolonged the time to symptomatic progression by 59%.

The company on Friday said ...