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About PEMAZYRE — 1 of 3
PEMAZYRE provides a new treatment option for
FGFR2 fusion-positive CCA
PEMAZYRE efficacy and safety was studied in FIGHT–202: a multicentre, open-label, single-arm study in previously treated patients with locally advanced/metastatic or surgically unresectable CCA1
Indication for use:
- 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 Swissmedic Professional Information)1*
Contraindications for use:
- Hypersensitivity to the active substance or to any of the excipients listed in the “Composition” section of the Swissmedic Professional Information1
- Concomitant use with St. John's wort (see the “Interactions” section of the Swissmedic Professional Information)1
PEMAZYRE offers clinically relevant and durable responses†
- ORR of 37.0% (n=40/108; 95% CI, 27.94–46.86), including 2.8% (n=3) CR and 34.3% (n=37) PR1
- Median DOR of 9.1 months (95% CI, 6.01–14.49)1
-
Kaplan-Meier estimates of DOR:1
- 6 months, 67.8% (95% CI, 50.4–80.3)
- 9 months, 50.5% (95% CI, 33.3–65.4)
- 12 months, 41.2% (95% CI, 24.8–56.8)
- Median PFS of 7.0 months (95% CI, 6.08–10.48)1
- Median OS of 17.5 months (95% CI, 14.36–22.93)1
PEMAZYRE safety profile
- The most common serious ARs were hyponatraemia (2.0%) and blood creatinine increase (1.4%)1
- No serious AR led to dose reduction1
- One serious AR of hyponatraemia (0.7%) led to dose interruption1
- One serious AR of blood creatinine increase (0.7%) led to dose discontinuation1
- Eye disorder serious ARs were retinal detachment (0.7%), non-arteritic optic ischaemic neuropathy (0.7%) and retinal artery occlusion (0.7%)1
*Due 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.1
†The efficacy population consisted of 108 patients that had progressed after at least 1 prior therapy and who had an FGFR2 fusion or rearrangement.1
For further information, please refer to the PEMAZYRE Swissmedic Professional Information.1
Date of preparation: January 2023
References
- PEMAZYRE® (pemigatinib) Swissmedic Professional Information, November 2022; https://www.swissmedicinfo.ch/ (accessed 16 December 2022).
- Rizvi S and Borad MJ. The rise of the FGFR inhibitor in advanced biliary cancer: the next cover of Time magazine? J Gastrointest Oncol. 2016;7:789–96.
- Ghouri YA, et al. Cancer review: Cholangiocarcinoma. J Carcinog. 2015;14:1.
- Sharma P and Yadav S. Demographics, tumor characteristics, treatment, and survival of patients with Klatskin tumors. Ann Gastroenterol. 2018;31:231–6.
- Blechacz B. Cholangiocarcinoma: Current knowledge and new developments. Gut Liver. 2017;11:13–26.
- Valle JW, et al. New horizons for precision medicine in biliary tract cancers. Cancer Discov. 2017;7:943–62.
- Bañales JM, et al. Cholangiocarcinoma 2020: The next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557–88.
- Bañales JM, et al. Expert consensus document: Cholangiocarcinoma: Current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016;13:261–80.
- Bertuccio P, et al. A comparison of trends in mortality from primary liver cancer and intrahepatic cholangiocarcinoma in Europe. Ann Oncol. 2013;24:1667–74.
- Blechacz B, et al. Clinical diagnosis and staging of cholangiocarcinoma. Nat Rev Gastroenterol Hepatol. 2011;8:512–22.
- Forner A, et al. Clinical presentation, diagnosis and staging of cholangiocarcinoma. Liver Int. 2019;39(suppl 1):98–107.
- Vogel A, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022; doi: https://doi.org/10.1016/j.annonc.2022.10.506.
- Lowery MA, et al. Comprehensive molecular profiling of intrahepatic and extrahepatic cholangiocarcinomas: potential targets for intervention. Clin Cancer Res. 2018;24:4154–61.
- Jain A, et al. Cholangiocarcinoma with FGFR genetic aberrations: A unique clinical phenotype. JCO Precis Oncol. 2018;2:1–12.
- Ross JS, et al. New routes to targeted therapy of intrahepatic cholangiocarcinomas revealed by next-generation sequencing. Oncologist. 2014;19:235–42.
- Farshidfar F, et al. Integrative genomic analysis of cholangiocarcinoma identifies distinct IDH-mutant molecular profiles. Cell Rep. 2017;18:2780–94.
- Graham RP, et al. Fibroblast growth factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Hum Pathol. 2014;45:1630–8.
- Churi CR, et al. Mutation profiling in cholangiocarcinoma: Prognostic and therapeutic implications. PLoS One. 2014;9:e115383.
- Arai Y, et al. Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma. Hepatology. 2014;59:1427–34.
- Borad MJ, et al. Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma. Curr Opin Gastroenterol. 2015;31:264–68.
- Silverman IM, et al. Clinicogenomic analysis of FGFR2-rearranged cholangiocarcinoma identifies correlates of response and mechanisms of resistance to pemigatinib. Cancer Discov. 2021;11:326–39.
- Barr FG. Fusion genes in solid tumors: The possibilities and the pitfalls. Expert Rev Mol Diagn. 2016;16:921–3.
- Liu PCC, et al. INCB054828 (pemigatinib), a potent and selective inhibitor of fibroblast growth factor receptors 1, 2, and 3, displays activity against genetically defined tumor models. PLoS One. 2020;15:e0231877.
- Abou-Alfa GK, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: A multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21:671–84.
All references are available upon request
Abbreviations
Abbreviated Prescribing Information
▼ This medicinal product is subject to additional monitoring. For further information, see product information Pemazyre on www.swissmedicinfo.ch/.
Revision date: November 2022.
Resources and support
For further information, please refer to the PEMAZYRE Swissmedic Professional Information.1
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