Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:

• The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations
• Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC
• Trial met its 1EP, improving rPFS, with BRCA1/2-mutated pts (n=191) showing unreached median rPFS vs 26mos. & a 48% reduction in rPFS. Akeega also prolonged the time to symptomatic progression & showed a 20% decrease in death risk; follow-up is ongoing

Ref: J&J  | Image: J&J  | Press Release

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