Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

Inclusion Criteria:

- Histologically or cytologically confirmed cholangiocarcinoma.

- Radiographically measurable or evaluable disease per RECIST v1.1.

- Tumor assessment for FGF/FGFR gene alteration status.

- Documented disease progression after at least 1 line of prior systemic therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

- Life expectancy ≥ 12 weeks.

Exclusion Criteria:

- Prior receipt of a selective FGFR inhibitor.

- History of and/or current evidence of ectopic mineralization/calcification, including
but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.

- Current evidence of clinically significant corneal or retinal disorder confirmed by
ophthalmologic examination.

- Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives,
whichever is shorter, before the first dose of study drug. Topical ketoconazole will
be allowed.