ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) in Japan

ONO and BMS Reports Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) in Japan


  • The companies have submitted the sBLA for the combination therapy to expand its use as 1L treatment of unresectable, advanced/ recurrent NSCLC in Japan, for a partial change in approved items of the manufacturing and marketing approval
  • The application is based on Part 1 of P-III CheckMate -227 study assessing the combination therapy vs CT in patients with CT-naïve stage IV or recurrent NSCLC whose tumors expressed PD-L1 ≥1%, resulted in improvement in OS
  • Opdivo is a PD-1 immune check inhibitor harnessing the body’s own immune system to restore anti-tumor immune response while Yervoy is mAb targeting cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) thus blocking its interaction with its ligands, CD80/CD86

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