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.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
Clinicians can use the PD-L1 IHC 22C3 pharmDx assay to help identify head and neck squamous cell carcinoma patients for treatment with Merck's Keytruda in Europe.