Johnson & Johnson Gains CHMP Positive Opinion for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:

• The CHMP has recommended label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations
• Opinion 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 improved time to symptomatic progression by 56% & showed an early OS trend with a 25% decrease in death risk; follow-up is ongoing

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

Related News: Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com