This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions

This medicinal product has been authorised under a 'conditional approval' scheme

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What is PEMAZYRE®?

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 therapy.1a

FGFR2 fusion positivity status must be known prior to initiation of PEMAZYRE therapy. Assessment for FGFR2 fusion positivity in tumour specimens should be performed with an appropriate diagnostic test.1

Pemigatinib is a kinase inhibitor of FGFR1, 2 and 3. It inhibits FGFR phosphorylation and signalling and decreases cell viability in cells expressing FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements.1

aThis medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited. The Medicines and Healthcare products Regulatory Agency will review new information on this medicinal product at least every year and the Summary of Product Characteristics will be updated as necessary.1

Reference:
1. PEMAZYRE® (pemigatinib). Summary of Product Characteristics.

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ESMO guideline recommendations

Discover more about ESMO guideline recommendations for patients with CCA.

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PEMAZYRE eDetail
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About PEMAZYRE

Learn more about the clinical data on PEMAZYRE.

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FGFR2 fusion testing

Discover more about FGFR2 fusions in patients with CCA.

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Dosing and administration

Learn more about the dosing and administration schedule of PEMAZYRE.

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PEMAZYRE self-directed learning

A self-directed learning material on PEMAZYRE is available to complete in your own time. With the PEMAZYRE learning module, you can learn about the clinical unmet needs in the treatment of CCA, discuss the need for molecular profiling for early patient identification and learn more about PEMAZYRE.

Learn about PEMAZYRE

PEMAZYRE eDetail