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 therapy1*
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Intended for licensed healthcare professionals located in the United Kingdom only.
Adverse reactions should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse reactions should be reported to Incyte® immediately by phoning the EU universal free phone number 00-800-0002-7423
This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited. Regulatory authorities will review new information on this medicinal product at least every year and the Summary of Product Characteristics will be updated as necessary.
Adverse reactions should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse reactions should be reported to Incyte® immediately by phoning the EU universal free phone number 00-800-0002-7423
This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited. Regulatory authorities will review new information on this medicinal product at least every year and the Summary of Product Characteristics will be updated as necessary.
Abbreviations
1L
first-line
2L
second-line
5-FU
5-fluorouracil
ASC
active symptom control
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
Eastern Cooperative Oncology Group
EGFR
epidermal growth factor receptor
ESMO
European Society for Medical Oncology
EU
European Union
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
MATE1
multidrug and toxin extrusion protein 1
MDT
multidisciplinary team
mg
milligram
mg/dL
milligram per decilitre
MHRA
Medicines and Healthcare products Regulatory Agency
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
P-gp
P-glycoprotein
PI
prescribing information
PPES
palmar-plantar erythrodysaesthesia syndrome
PR
partial response
PS
performance status
RECIST
Response Evaluation Criteria in Solid Tumours
SmPC
Summary of Product Characteristics
SOC
standard of care
Prescribing Information
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