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

 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

Shots:

  • 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

Click here to­ read full press release/ article | Ref: ONO | Image: ONO

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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