Incyte Corporation — Pemazyre EMA EPAR public assessment report (EMEA/H/C/005266, 2021)

Report summary

This EMA report details the assessment of Pemazyre (pemigatinib) for treating locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement in adults who have progressed after prior systemic therapy. The drug's mechanism, non-clinical safety, and pharmacokinetics are discussed, noting potential human effects like hyperphosphatemia. Clinical trials, including the pivotal FIGHT-202 study, demonstrated efficacy, particularly in patients with FGFR2 rearrangements (Cohort A), showing an Objective Response Rate of 35.5%. Common adverse events include hyperphosphatemia and serous retinal detachment. Due to unmet medical needs and promising anti-tumor activity, conditional marketing authorization was granted, with ongoing studies to confirm efficacy and safety. The FDA also granted accelerated approval.

Key findings — cited to the page