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Every dated change on the records linked to Biliary tract cancer (cholangiocarcinoma), newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement (REFOCUS)
When this page itself was last checked or edited.
Previously treated unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement
HER2-positive (IHC 3+) unresectable locally advanced or metastatic biliary tract cancer after at least one line of systemic treatment; MHRA 19 February 2026, NICE TA1153 published 7 May 2026 with a commercial arrangement
NRG1-fusion cholangiocarcinoma
Contrast CT/MRI with MRCP; ERCP or EUS-guided biopsy; molecular profiling (DNA + RNA NGS) for all advanced disease; biliary drainage if jaundiced. (NCCN Molecular testing recommended (category 2A))
A milestone in how this cancer is treated.
Locally advanced, unresectable or metastatic biliary tract cancer with gemcitabine and cisplatin; NICE TA944 recommended 10 January 2024 with a commercial arrangement
Locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement after at least one systemic treatment; NICE TA1005 recommended 11 September 2024 as an alternative to pemigatinib
Locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation after one or more systemic treatments; NICE TA948 recommended 31 January 2024 with a commercial arrangement
HER2+ (IHC 3+) unresectable/metastatic biliary tract cancer, previously treated
OS 6.
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
Locally advanced unresectable or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (KEYNOTE-966)
3-year overall survival 77.
Endometrial ORR 57.
Confirmed ORR by independent central review 41.
OS 12.
A milestone in how this cancer is treated.
Locally advanced or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (TOPAZ-1)
Previously treated FGFR2-fusion/rearranged intrahepatic cholangiocarcinoma (accelerated)
ORR 42%; PFS 9.
OS HR 0.
ORR 9.
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
Previously treated unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement (accelerated approval)
Previously treated IDH1-mutated cholangiocarcinoma
IDH1 companion claim in cholangiocarcinoma (ivosidenib)
Locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement after systemic therapy; NICE TA722 recommended 25 August 2021 with a commercial arrangement
BICR PFS 7.
A milestone in how this cancer is treated.
Previously treated FGFR2-fusion/rearranged cholangiocarcinoma (accelerated)
PFS HR 0.
ORR 37%; PFS 7.
Biliary cohort ORR 5.
Biliary cohort ORR 51% (22/43, investigator) and 47% (independent review); grade 3 or worse GGT rise 12%.
A milestone in how this cancer is treated.
A milestone in how this cancer is treated.
Modified FOLFOX plus active symptom control modestly improved overall survival over active symptom control alone.
Median PFS 11.