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What is CCA? Unmet needs in CCA Molecular profiling for early patient identification About PEMAZYRE Clinical benefit with PEMAZYRE Safety profile for PEMAZYRE PEMAZYRE dosing and administration Resources and support

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

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CH/PEMA/P/23/0006
Date of preparation: April 2023
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