A recent paper details how, across several cancer types, high TMB is associated with improved outcomes with immunotherapy but worse outcomes without it.
The European Commission will review CHMP's opinion based on the Keynote-177 data and is expected to issue a final decision in the first quarter of 2021.
The new consortium is aiming to make comprehensive genomic profiling accessible to advanced cancer patients in the US, to help inform their treatment decisions.
Researchers are continuing to collect data on economic, racial, and other factors that could be addressed to make precision medicine access more equitable.
Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.
The approval is supported by a randomized trial showing that pembrolizumab nearly doubled progression-free survival compared to the standard chemotherapy regimen.
Based on an eight-month progression-free survival advantage in Keynote-177, oncologists said that Keytruda may be the new frontline option for this subset of patients.
The drugmaker will cover the cost of testing for up to 500 patients in the US with MSI-high colorectal cancer or RAI-refractory differentiated thyroid cancer.
