Bristol-Myers Squibb has withdrawn its application for FDA approval of a treatment that combined Opdivo with the drugmaker's other immune-oncology drug, Yervoy, after the combo proved unimpressive in trials.
The drugmaker withdrew its sBLA, initially accepted in June 2018, for the combo for the frontline treatment of patients with advanced non–small cell lung cancer (NSCLC) with tumor mutational burden, following discussions with the FDA. In October, BMS had submitted updated data and the agency had extended the review period by three months. However, the new data showed no difference in survival outcomes between patients whose tumors had high or low levels of TMB.
BMS believes further evidence on the relationship between TMB and PD-L1 is required to fully evaluate the impact of Opdivo plus Yervoy — information that will not be available within the review period of the current application. As such, BMS chose to withdraw the sBLA.
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