FDA Approves Janssen Biotech’s Akeega for BRCA2-Mutated mCSPC

The FDA gave Janssen Biotech approval for Akeega (niraparib and abiraterone acetate) to treat BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).

• Efficacy comes from AMPLITUDE trial
  • Showed a statistically significant improvement in radiographic progression-free survival for niraparib and abiraterone acetate plus prednisone compared to placebo and AAP in the overall population of patients with homologous recombination repair gene-mutated

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Ilya Banares at ibanares@bloomberg.net

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