PEMAZYRE® (pemigatinib)
PEMAZYRE monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy1a
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aThis medicinal product has been authorised under a ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. The EMA will review new information on this medicinal product at least every year and the SmPC will be updated as necessary.1
Abbreviations
1L
first-line
2L
second-line
5-FU
5-fluorouracil
ABC
advanced biliary tract cancer
Amp
Amplification
API
abridged product information
AR
adverse reaction
ASC
active symptom control
BRAF
v-raf murine sarcoma viral oncogene homolog B1
BRCA
breast cancer gene
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
Eastern Cooperative Oncology Group
EGFR
epidermal growth factor receptor
EMA
European Medicines Agency
ERBB
erb-b2 receptor tyrosine kinase
ERK
extracellular signal-regulated kinase
ESMO
European Society for Medical Oncology
EU
European Union
FDA
(United States) Food and Drug Administration
FGFR
fibroblast growth factor receptor
FOLFOX
folinic acid, fluorouracil and oxaliplatin
HER/neu
Human epidermal growth factor receptor
HR
hazard ratio
iCCA
intrahepatic cholangiocarcinoma
IDH
isocitrate dehydrogenase
KM
Kaplan-Meier
KRAS
Kirsten rat sarcoma viral oncogene homolog
MAPK
mitogen-activated protein kinase
MATE
multidrug and toxin extrusion protein
MDM
mouse double minute 2 homolog
MDT
multidisciplinary team
MET
mesenchymal epithelial transition proto-oncogene
mg
milligram
mg/dL
milligram per decilitre
MSI-H
microsatellite instability-high
Mut
mutation
NADPH
nicotinamide adenine dinucleotide phosphate
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
PD
programmed cell death protien
pCCA
perihilar cholangiocarcinoma
P-gp
P-glycoprotein
PPES
palmar-plantar erythrodysaesthesia syndrome
PR
partial response
PS
performance status
RAS
rat sarcoma virus
RAF
rapidly accelerated fibrosarcoma
RECIST
Response Evaluation Criteria in Solid Tumours
SmPC
Summary of Product Characteristics
SOC
standard of care
TMB
tumour mutational burden
TP
tumour protein
Sweden API
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