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.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The findings should spur cancer centers to review testing rates and address barriers, said experts from Hackensack University, Cota Healthcare, and Guardant Health.
