Intended for licensed healthcare professionals located in Denmark.
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.1*
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
*This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited. The European Medicines 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
1. PEMAZYRE® (pemigatinib). Summary of Product Characteristics: Sections 4.1, 4.2 and 5.1. June 2022.