References

Swiss Professional Information PEMAZYRE^® (pemigatinib) on www.swissmedicinfo.ch.
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All references are available upon request

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

^▼ This medicinal product is subject to additional monitoring. For further information, see product information Pemazyre on www.swissmedicinfo.ch.

PEMAZYRE (pemigatinib), tablets of 13.5 mg, 9 mg, 4.5 mg. I: As monotherapy for the treatment of adults with locally advanced, unresectable or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one line of systemic therapy. P: Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer. FGFR2 fusion positivity status must be confirmed prior to initiation of therapy. Pemazyre 13.5 mg is taken orally once per day for 14 days, followed by 7 days off therapy. For dose adjustments due to adverse reactions, see www.swissmedicinfo.ch. For patients with severe hepatic or renal impairment, the dose should be reduced to the next lower strength. CI: Hypersensitivity to the active substance or to any of the excipients. Concomitant use with St John’s wort. W/P: Pemazyre is associated with hyper- and hypophosphatemia, serous retinal detachment, dry eye and blood creatinine increase. Pemazyre can cause fetal harm. Women of childbearing potential should be advised not to become pregnant and men not to father a child during treatment. IA: Concomitant administration with proton pump inhibitors, strong CYP3A4 inhibitors or inducers should be avoided. Administration should be separated by at least 6 hours before or after administration of P-gp substrates with a narrow therapeutic index. Close clinical surveillance is recommended when co-administered with CYP2B6 substrates. UE: The most common adverse reactions (≥ 30%) were hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, nausea, stomatitis, constipation, dysgeusia and dry mouth. The most common serious adverse reactions were hyponatremia and increased blood creatinine. For further information on UE, see www.swissmedicinfo.ch. Dispensing cat.: A.
Revision date: January 2023. Marketing authorisation holder: Incyte Biosciences International Sàrl, CH-1110 Morges. Refer to www.swissmedicinfo.ch for detailed information.

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About PEMAZYRE — 2 of 3

PEMAZYRE is the first approved, molecularly targeted treatment for FGFR2 fusion-positive CCA

Pemigatinib is a potent inhibitor of FGFR1, 2 and 3^1,23