Shots:

• The approval is based on P-III CheckMate -9ER trial involves assessing Cabometyx + Opdivo vs sunitinib in 651 patients with previously untreated advanced/m-RCC
• The results demonstrated significant improvement across all efficacy EPs. The trial met its 1EPs i.e. showed doubled mPFS (16.6 vs 8.3mos.); ORR (55.7% vs. 27.1%); CR (8.0% vs 4.6%); OS (40% reduction in risk of death)- improvement in DCR with a lower rate of discontinuation- consistent efficacy benefits observed across key subgroups of patients and was well tolerated
• The approval allows for the marketing of combination regimen in all 27 member states of the EU- Norway- Liechtenstein- and Iceland

  Ref: Business Wire | Image: Business Wire