The firm is exploring whether the regimen may work for subgroups of patients with high TMB based on promising signals from the current failed analysis.
The CheckMate-650 trial showed the potential of combined immunotherapy in metastatic, castration-resistant prostate cancer and identified subgroups for further study.
A consortium convened by Friends of Cancer Research has made progress in quantifying sources of TMB assay discordance and created a new test-alignment software tool.
Over the last six months the agency approved 21 cancer treatments for molecularly defined indications compared to 12 during the same period last year and 20 during all of 2019.
Some oncologists said 10 mutations/Mb is an acceptable TMB cutoff in patients who are out of options, while others worry it will drive immunotherapy use in those unlikely to have a lasting benefit.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
