FDA Expands Approval for PD-L1 Diagnostic Test in Cancer Treatment

The U.S. Food and Drug Administration has broadened the approved applications for the automated PD-L1 IHC 22C3 pharmDx assay. This expansion enables pathology labs to utilize the diagnostic tool for guiding treatment decisions in four additional solid tumor types, including certain breast and cervical cancers. The approval facilitates more targeted immunotherapy with pembrolizumab (Keytruda) for these indications.