MMR/MSI in biliary tract cancer

1 EU-approved indication in biliary tract cancer needs a MMR/MSI result: pembrolizumab (2nd line, advanced).

Line of therapy

Approved indications, Biliary tract cancer
DrugBiomarker requirementRegimenSettingConditions
dMMR / MSI-H1
Monotherapy
2L
advanced
Disease progression on or following at least one prior therapy

2 approvals for BTC need no biomarker and apply whatever the result. All approvals for BTC

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Pembrolizumab (Keytruda)
    unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.