BMS pulls sBLA for Opdivo/Yervoy combo in first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said it has voluntarily withdrawn its sBLA for anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line treatment of lung cancer, citing a need for more evidence of the relationship between PD-L1 and tumor mutational burden (TMB).

BMS, which revealed the news in its 4Q18 earnings announcement Thursday, said recent discussions with FDA suggest those data will be required to fully evaluate the effect of the Opdivo/Yervoy combination on overall survival (OS) in first-line non-small cell lung cancer patients...