PEMAZYRE® (pemigatinib)
PEMAZYRE is indicated as monotherapy for the treatment of adults with locally advanced, unresectable or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, that have progressed after at least one line of systemic therapy (see the “Clinical efficacy” section of the Swissmedic Professional Information).1
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Abbreviations
1L
first-line
5-FU
fluorouracil
AR
adverse reaction
BRAF
v-raf murine sarcoma viral oncogene homolog B1
BTC
biliary tract cancer
CCA
cholangiocarcinoma
CI
confidence interval
CNS
central nervous system
CR
complete response
CYP2B6
cytochrome P450 2B6
CYP3A4
cytochrome P450 3A4
dCCA
distal cholangiocarcinoma
dMMR
mismatch repair deficient
DOR
duration of response
eCCA
extrahepatic cholangiocarcinoma
ECOG PS
Eastern Cooperative Oncology Group Perfomance Status
EGFR
epidermal growth factor receptor
EMA
European Medicines Agency
ESCAT
ESMO Scale for Clinical Actionability of Molecular Targets
ESMO
European Society for Medical Oncology
EU
European Union
FDA
US Food and Drug Administration
FGFR
fibroblast growth factor receptor
FOLFOX
folinic acid, fluorouracil and oxaliplatin
HER
human epidermal growth factor receptor
iCCA
intrahepatic cholangiocarcinoma
IDH
isocitrate dehydrogenase
KM
Kaplan-Meier
KRAS
Kirsten rat sarcoma viral oncogene homolog
MATE1
multidrug and toxin extrusion protein 1
MDT
multidisciplinary team
mg
milligram
mg/dL
milligram per decilitre
MSI-H
microsatellite instability-high
NGS
next-generation sequencing
NTRK
neurotrophic tyrosine receptor kinase
OCT
optical coherence tomography
OCT2
organic cation transporter-2
ORR
overall response rate
OS
overall survival
pCCA
perihilar cholangiocarcinoma
PD-1
programmed cell death protein
PFS
progression-free survival
P-gp
P-glycoprotein
PI
Prescribing Information
PPES
palmar-plantar erythrodysaesthesia syndrome
PR
partial response
RECIST
Response Evaluation Criteria in Solid Tumours
Abbreviated Prescribing Information
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