Intended for licensed healthcare professionals located in Switzerland.
PEMAZYRE is indicated as monotherapy for the treatment of adults with locally advanced, unresectable or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, that have progressed after at least one line of systemic therapy (see the “Clinical efficacy” section of the Swiss Professional Information).a
FGFR2 fusion positivity status must be confirmed prior to initiation of PEMAZYRE therapy. Assessment for FGFR2 fusion positivity in tumour specimens should be performed with a validated diagnostic test.
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.
aDue to incomplete clinical data at the time of review of the marketing authorisation application, the medicinal product PEMAZYRE is authorised for a limited period of time (Art. 9a LPTh). The temporary authorisation must be linked to the timely satisfaction of conditions. Once these conditions are met, the temporary authorisation may be converted into ordinary authorisation.
Swiss Professional Information PEMAZYRE® (pemigatinib) on www.swissmedicinfo.ch.