BMS Reports the US FDA Acceptance of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment for Non-Small Cell Lung Cancer

Shots:

• The US FDA has accepted sBLA for the dual regimen as 1L treatment for metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations and has granted the PR status to the therapy
• The application is based on part 1 of P-III CheckMate -227 study results assessing Opdivo + Yervoy vs platinum-doublet CT in patients with 1L NSCLC demonstrating improvement in OS with no new safety signals
• 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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