About PEMAZYRE — 1 of 3

PEMAZYRE provides a treatment option for patients with
FGFR2 fusion-positive CCA

PEMAZYRE efficacy and safety were 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 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 therapy1*

Contraindications for use:

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the PEMAZYRE Summary of Product Characteristics1
  • Concomitant use with St Johns’ wort1


  • 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 9.13 months (95% CI, 6.01–14.49)1
  • KM 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)

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

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