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

Bristol-Myers Squibb Co. (NYSE:BMY) said it has withdrawn an sBLA for anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line treatment of lung cancer, citing a need for more evidence of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 Jan. 24, said recent discussions with FDA suggest those data will be required to evaluate in full the effect of the Opdivo/Yervoy combination on overall survival in first-line non-small cell lung cancer patients...