regulatory approval

The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.

The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1. 

This is the third drug the agency has approved with a pan-cancer indication.

The diagnostic can now be used to identify patients with esophageal squamous cell carcinoma who may benefit from first-line treatment with Keytruda.

CHMP endorsed the immunotherapy combination for women in Europe with triple-negative, advanced cancers based on results from a Phase III trial reported last December.

The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.

The drugmaker has also submitted data on this tissue-agnostic treatment indication with US and European regulators.

The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.