What changed: Biliary tract cancer (cholangiocarcinoma)
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.
September 2026 · 1
Q2 2026 · 1
2026 · 3
- 2026ApprovalZenocutuzumabZenocutuzumab approved in US
NRG1-fusion cholangiocarcinoma
- 2026GuidelineBiliary tract cancer (cholangiocarcinoma)Guideline NCCN Biliary Tract Cancers 2026: Diagnosis and staging
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))
- 2026MilestoneZenocutuzumabZenocutuzumab approved for NRG1-fusion cholangiocarcinoma; HERIZON-BTC-302 enrolling
A milestone in how this cancer is treated.
2025 · 1
November 2024 · 1
2024 · 4
- 2024ApprovalZanidatamabZanidatamab approved in US
HER2+ (IHC 3+) unresectable/metastatic biliary tract cancer, previously treated
- 2024Trial resultNALIRICC (AIO)NALIRICC (AIO) reported
OS 6.
- 2024MilestoneZanidatamabZanidatamab for HER2+ BTC
A milestone in how this cancer is treated.
- 2024MilestoneZanidatamabZanidatamab: first HER2 approval in biliary cancer; T-DXd tumour-agnostic HER2 IHC3+; NALIRICC negative
A milestone in how this cancer is treated.
January 2023 · 1
2023 · 3
September 2022 · 1
2022 · 5
- 2022ApprovalFutibatinibFutibatinib approved in US
Previously treated FGFR2-fusion/rearranged intrahepatic cholangiocarcinoma (accelerated)
- 2022Trial resultFOENIX-CCA2FOENIX-CCA2 reported
ORR 42%; PFS 9.
- 2022Trial resultTOPAZ-1TOPAZ-1 reported
OS HR 0.
- 2022MilestoneTOPAZ-1TOPAZ-1: first immunotherapy approval; futibatinib approved
A milestone in how this cancer is treated.
- 2022MilestoneDurvalumabTOPAZ-1: immunotherapy first line
A milestone in how this cancer is treated.
2021 · 5
- 2021ApprovalInfigratinibInfigratinib approved in US
Previously treated unresectable or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement (accelerated approval)
- 2021ApprovalIvosidenibIvosidenib approved in US
Previously treated IDH1-mutated cholangiocarcinoma
- 2021ApprovalOncomine Dx Target TestOncomine Dx Target Test approved in US
IDH1 companion claim in cholangiocarcinoma (ivosidenib)
- 2021ApprovalPemigatinibPemigatinib approved in EU
Same
- 2021MilestoneIvosidenibIvosidenib approved (ClarIDHy); infigratinib approved then withdrawn (2022)
A milestone in how this cancer is treated.
2020 · 5
- 2020ApprovalPemigatinibPemigatinib approved in US
Previously treated FGFR2-fusion/rearranged cholangiocarcinoma (accelerated)
- 2020Trial resultClarIDHyClarIDHy reported
PFS HR 0.
- 2020Trial resultFIGHT-202FIGHT-202 reported
ORR 37%; PFS 7.
- 2020MilestoneBiliary tract cancer (cholangiocarcinoma)Pemigatinib: first FGFR2 inhibitor
A milestone in how this cancer is treated.
- 2020MilestonePemigatinibPemigatinib: first targeted approval in biliary cancer
A milestone in how this cancer is treated.