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ESMO guideline recommendations FGFR2 fusion testing
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ESMO guideline
recommendations

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FGFR inhibitors are now recommended by ESMO1

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The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines now recommend the use of approved fibroblast growth factor receptor (FGFR) inhibitors (such as PEMAZYRE) for the treatment of patients with cholangiocarcinoma (CCA) harbouring FGFR2 fusions whose disease has progressed after ≥1 prior line of systemic therapy.1,a

Secondary resistance mutations to reversible adenosine triphosphate-competitive FGFR inhibitors have been identified, which may be amenable to subsequent therapies with irreversible FGFR inhibitors.1

The use of RNA-based next-generation sequencing (NGS) panels that can identify fusion transcripts of known and unknown fusion partners is the preferred method of detecting FGFR2 fusions or rearrangements in patients with CCA.1

Learn more about the ESMO recommendations for CCA

Click below for more key recommendations:1

The ESMO Clinical Practice Guidelines treatment algorithm1

Chart highlighting a path from Billary tract cancer diagnosis to PEMAZYRE via FGFR2 fusion

Adapted from Annals of Oncology, Volume 34/Issue 2, Vogel A, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up, P127-401, with permission from the European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

5-FU, 5-fluorouracil; BRAF, B-Raf proto-oncogene; dMMR, mismatch repair deficiency; ESMO, European Society for Medical Oncology; FGFR2, fibroblast growth factor receptor 2; FOLFOX, 5-fluorouracil-leucovorin-oxaliplatin; iCCA, intrahepatic cholangiocarcinoma; IDH1, isocitrate dehydrogenase 1; HER2, human epidermal growth factor receptor 2; MDT, multidisciplinary team; MSI-H, microsatellite instability-high.

aPEMAZYRE monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy;2
bEuropean Medicines Agency (EMA) and US Food and Drug Administration (FDA) approved.
cFDA approved; not EMA approved.
dAnti-programmed cell death protein 1 therapy is recommended for patients with miscrosatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) who have not been treated with first-line immunotherapy.
eEMA approved for MSI-H/dMMR biliary tract cancer; FDA approved for all MSI-H/dMMR solid tumours.
fNot EMA approved; not FDA approved.

References:
1. Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127–40.
2. PEMAZYRE® (pemigatinib). Summary of Product Characteristics: Section 4.1 on www.fass.se.

All references available upon request.

Biopsy

  • A core biopsy should be obtained for diagnostic pathology and molecular profiling before any non-surgical treatment

Reference:
Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127–40.

Molecular profiling

  • Discussion with a molecular pathologist or the molecular tumour board is strongly recommended when considering molecular profiling
  • Molecular profiling should be performed before or during first-line therapy using next-generation sequencing (NGS)
  • NGS can be performed on formalin-fixed and paraffin-embedded tumour tissue and is well suited for tissue biopsies
  • Alternatively, liquid biopsies using cell-free circulating DNA may be considered, if not enough tumour tissue is available for NGS
  • Results of molecular profiling may help to determine eligibility for second-line targeted therapies, should the patient experience disease progression on first-line therapy

Reference:
Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127–40.

DNA-based next-generation sequencing (NGS)

  • NGS gene panels that include isocitrate dehydrogenase 1 (IDH1), human epidermal growth factor receptor 2 (HER2/neu) and B-Raf proto-oncogene (BRAF) should be used to test for hotspot mutations, but owing to the evolving landscape of drug targets and predictive biomarkers, this may soon necessitate larger panels
  • DNA-based NGS assays should ideally employ hybrid capture or anchored multiplex polymerase chain reaction (PCR) technology

Reference:
Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127–40.

RNA-based next-generation sequencing (NGS)

  • For tissue-based testing, gene fusions involving the fibroblast growth factor 2 (FGFR2) and neurotrophic tyrosine receptor kinase (NTRK) genes should preferably be interrogated at the RNA level using a panel-based method that can identify fusion transcripts of known and unknown fusion partners
  • RNA-based NGS assays should ideally employ hybrid capture or anchored multiplex polymerase chain reaction (PCR) technology

Reference:
Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34(2):127–40.

Learn more about PEMAZYRE® (pemigatinib):

Targeted medicine

Discover about FGFR2 fusions in patients with CCA

Targeted medicine FGFR2 fusion testing
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Understand the dosing and administration schedule for PEMAZYRE

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PEMAZYRE eDetail

▼Detta läkemedel är föremål för utökad övervakning. Detta kommer att göra det möjligt att snabbt identifiera ny säkerhetsinformation. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning. Se avsnitt 4.8 om hur man rapporterar biverkningar.

Prescribing InformationPemazyre (pemigatinib), 4,5, mg, 9 mg, 13,5 mg, tabletter. Rx. EF.
ATC-kod: LO1E N02, antineoplastiska medel, proteinkinashämmare. Indikation: Pemazyre som monoterapi är indicerat för behandling av vuxna patienter med lokalt avancerat eller metastaserat kolangiokarcinom, med fusion eller rearrangemang av fibroblasttillväxtfaktorreceptor 2 (FGFR2) som har progredieratefter minst en tidigare linjes systemisk behandling. Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne som anges i avsnitt 6.1 i produktresumén. Samtidig användning med johannesört. Varningar och försiktighet: Permigatinib kan orsaka hyperfosfatemi, svår hypofosfatemi, exudativa näthinneavlossningsreaktioner, torra ögon och ökad serumkreatinin genom att minska renal tubulär sekretion av kreatinin. Samtidig användning av pemigatinib och protonpumpshämmare ska undvikas. Samtidig användning av pemigatinib och starka CYP3A4-hämmare kräver dosjustering. Patienterna ska rådas att undvika att äta grapefrukt och att dricka grapefruktjuice vid behandling med pemigatinib. Samtidig användning av pemigatinib och starka eller måttliga CYP3A4-inducerare rekommenderas inte. Baserat på fynd i en djurstudie och dess verkningsmekanism kan Pemazyre orsaka fosterskador när det ges till en gravid kvinna. Gravida kvinnor ska även informeras om den potentiella risken för fostret. Fertila kvinnor som behandlas med Pemazyre ska avrådas från att bli gravida och män som behandlas med Pemazyre ska avrådas från att göra en kvinna gravid under behandlingen. En effektiv preventivmedelsmetod ska användas hos fertila kvinnor och hos män med fertila kvinnliga partners under behandling med Pemazyre och under en vecka efter avslutad behandling. Effekter på förmågan att framföra fordon och använda maskiner: Pemigatinib har måttlig effekt på förmågan att framföra fordon och använda maskiner. Biverkningar som trötthet och synstörningar har förknippats med pemigatinib. Försiktighet ska därför iakttas vid framförande av fordon eller användning av maskiner.
MAH: Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederländerna. För mer information se www.fass.se. Senaste datum för översyn av produktresumén: 2023-07-26.

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Paasheuvelweg 25
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Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to their local authority or to Incyte (by e-mail: eumedinfo@incyte.com).

Local representative: John Eriksson, Key Account Manager | Email: jeriksson@incyte.com | Phone: +46 73 440 88 12

SE/PEMA/P/23/0003
Date of preparation: November 2023
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