The indication is for patients with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. These genetic abnormalities occur in 10%-16% of patients, according to Incyte, the maker of pemigatinib.
Pemigatinib is a kinase inhibitor and was approved by the US Food and Drug Administration for this same indication 1 year ago.
Pemigatinib "is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care," said Hervé Hoppenot, chief executive officer of Incyte, in a press statement.
"Pemazyre offers a much-needed option to eligible patients that have only had few effective treatment options until today," said Eric Van Cutsem, MD, PhD, of the University of Leuven in Leuven, Belgium, in the same statement.
Interim results from the trial demonstrated that among a cohort of 107 patients harboring FGFR2 fusions or rearrangements, pemigatinib monotherapy resulted in an overall response rate, which was the primary endpoint, of 37% and a median duration of response, a secondary endpoint, of 8 months.
Previously released safety information involving 146 patients in the three cohorts showed that pemigatinib was generally well tolerated, said the company. Grade 1 or 2 hyperphosphatemia was the most common treatment-emergent adverse event (60%) and was managed with a low phosphate diet, phosphate binders and diuretics, or dose reduction or interruption.
The most common grade 3 or higher treatment-emergent adverse event was hypophosphatemia (12%); none of the cases was considered clinically significant or serious and none led to dose reduction or discontinuation.
The new drug carries warnings and precautions for ocular toxicity. Serous retinal detachment was observed in 4% of patients (grade ≥3, 1%). However, none of the cases resulted in clinical sequelae, said the company.
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Cite this: Europe Approves Pemigatinib for Bile Duct Cancer - Medscape - Mar 31, 2021.