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Ref Type
PMID
Authors
Title Pemazyre (pemigatinib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213736
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Pemigatinib Pemigatinib 141 20
Drug Name Trade Name Synonyms Drug Classes Drug Description
Pemigatinib Pemazyre INCB54828|INCB054828 FGFR1 Inhibitor 28 FGFR2 Inhibitor 23 FGFR3 Inhibitor 19 Pemazyre (pemigatinib) is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR1/2/3 signaling, which results in growth inhibition in tumor cells (PMID: 32203698). Pemazyre (pemigatinib) is FDA approved for use in patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement, and in adult patients with relapsed or refractory myeloid or lymphoid neoplasms harboring FGFR1 rearrangement (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR1 rearrange myeloid and lymphoid neoplasms associated with FGFR1 abnormalities sensitive Pemigatinib FDA approved Actionable In a Phase II trial (FIGHT-203) that supported FDA approval, Pemazyre (pemigatinib) treatment resulted in a complete response rate of 64.5% (20/31) and a complete cytogenetic response rate of 72.2% (24/33) in adult patients with relapsed or refractory myeloid or lymphoid neoplasms harboring FGFR1 rearrangements, with median duration of complete response not reached (Blood (2021) 138 (Supplement 1): 385; NCT03011372). detail... detail...
FGFR2 rearrange cholangiocarcinoma sensitive Pemigatinib FDA approved - On Companion Diagnostic Actionable In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376). detail... 32203698 detail...
FGFR2 fusion cholangiocarcinoma sensitive Pemigatinib FDA approved - On Companion Diagnostic Actionable In a Phase II (FIGHT-202) trial, Pemazyre (pemigatinib) treatment resulted in an objective response in 35.5% (38/107, 3 complete response, 35 partial response) of patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a disease control rate of 82% (88/107), median time-to-response of 2.7 months, and a median progression-free survival of 6.9 months (PMID: 32203698; NCT02924376). detail... 32203698 detail...