FDA accepts sBLA for Opdivo + low dose Yervoy for the treatment of first-line NSCLC in patients with tumor mutational burden . -BMS.
Bristol-Myers Squibb Company announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) greter than 10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 2019.
The application was based on results from Part 1 of CheckMate -227, the first and only global Phase III study to evaluate an I-O/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB greater than 10 mut/Mb, across squamous and non-squamous tumor histologies and the PD-L1 expression spectrum. These data were presented at the American Association for Cancer Research Annual Meeting 2018 and published in The New England Journal of Medicine.
About Tumor Mutational Burden (TMB)- Over time, cancer cells accumulate mutations that are not seen in normal cells of the body. Tumor mutational burden, or TMB, is a quantitative biomarker that reflects the total number of mutations carried by tumor cells. Tumor cells with high TMB have higher levels of neoantigens, which are thought to help the immune system recognize tumors and incite an increase in cancer-fighting T cells and an anti-tumor response. TMB is one type of biomarker that may help predict the likelihood a patient responds to immunotherapies.
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