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Profile Name	FGFR2 rearrange
Gene Variant Detail	FGFR2 rearrange (unknown)
Relevant Treatment Approaches	FGFR Inhibitor (Pan) FGFR2 Inhibitor

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Showing 1 to 14 of 14 entries

Molecular Profile	Indication/Tumor Type	Response Type	Relevant Treatment Approaches	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR2 Inhibitor	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 rearrange	intrahepatic cholangiocarcinoma	sensitive	FGFR Inhibitor (Pan)	Futibatinib	FDA approved	Actionable	In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated safety and resulted in an objective response rate of 42% (43/103, 1 complete response, 42 partial responses), disease control rate of 83% (85/103), median duration of response of 9.7 mo, median progression-free survival of 9.0 mo, and median overall survival of 21.7 mo in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 36652354; NCT02052778).	detail... 36652354
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR2 Inhibitor	Pemigatinib	Guideline	Actionable	Pemazyre (pemigatinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org).	detail...
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR Inhibitor (Pan)	Futibatinib	Guideline	Actionable	Lytgobi (futibatinib) is included in guidelines as subsequent-line therapy (category 2A) for patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement (NCCN.org).	detail...
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR Inhibitor (Pan)	Futibatinib	Guideline	Actionable	Lytgobi (futibatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions and rearrangements (PMID: 39864891; ESMO.org).	detail... 39864891
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR2 Inhibitor	Pemigatinib	Guideline	Actionable	Pemazyre (pemigatinib) is included in guidelines as second or later-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (PMID: 39864891; ESMO.org).	detail... 39864891
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR Inhibitor (Pan)	Erdafitinib	Guideline	Actionable	Balversa (erdafitinib) is included in guidelines as subsequent-line therapy for patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements (NCCN.org).	detail...
FGFR2 rearrange	cholangiocarcinoma	predicted - sensitive	FGFR Inhibitor (Pan)	Infigratinib	Phase II	Actionable	In a Phase II trial, Truseltiq (infigratinib) treatment demonstrated manageable toxicity, resulted in an objective response rate of 23.1% (25/108, 1 complete response, 24 partial responses) in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 fusion or rearrangement, with a median duration of response of 5.0 months and a median progression-free survival of 7.3 months (J Clin Oncol 39, no. 3_suppl (January 20, 2021) 265-265; NCT02150967).	detail...
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR2 Inhibitor	Pemigatinib	Clinical Study	Actionable	In a retrospective analysis, Pemazyre (pemigatinib) demonstrated safety and efficacy in real-world patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, resulting in an objective response rate of 45.8% (33/72, 2 complete and 31 partial responses), disease control rate of 84.7% (61/72), with median duration of response of 7 mo, median progression-free survival of 8.7 mo, and median overall survival of 17.1 mo (PMID: 38340384).	38340384
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR Inhibitor (Pan)	Futibatinib	Case Reports/Case Series	Actionable	In a Phase I trial, Lytgobi (futibatinib) treatment resulted in partial response in 2 patients with cholangiocarcinoma harboring FGFR2 rearrangements (Annals of Oncology, Volume 29, Issue suppl_5).	detail...
FGFR2 rearrange	pancreatic ductal adenocarcinoma	predicted - sensitive	FGFR Inhibitor (Pan)	Erdafitinib	Case Reports/Case Series	Actionable	In a clinical case study, Balversa (erdafitinib) treatment resulted in decrease in the pulmonary lesions, symptom improvement, and decreased CA 19-9 levels with treatment continuing at least 12 months in a patient with pancreatic ductal adenocarcinoma harboring an FGFR2 rearrangement (PMID: 36240849).	36240849
FGFR2 rearrange	breast cancer	no benefit		Sunitinib	Case Reports/Case Series	Actionable	In a Phase II trial (TAPUR), Sutent (sunitinib) treatment did not meet the predetermined efficacy criteria in metastatic breast cancer patients with FGFR2 amplification (n=2), FGFR2 mutation (including FGFR2 rearrangement) (n=6), or both (n=2), resulting in no objective responses or stable disease of at least 16 weeks, median progression-free survival of 8 weeks, and a median overall survival of 22 weeks (PMID: 38354330; NCT02693535).	38354330
FGFR2 rearrange	Her2-receptor negative breast cancer	predicted - sensitive	FGFR2 Inhibitor	Tinengotinib	Case Reports/Case Series	Actionable	In a Phase I trial, Tinengotinib (TT-00420) treatment was well tolerated and resulted in stable disease in 53.3% (23/43) and partial response in 16.3% (7/43) of patients with advanced solid tumors, including a partial response in a patient with hormone receptor-positive, ERBB2 (Her2)-negative breast cancer harboring an FGFR2 rearrangement (PMID: 38297981; NCT03654547).	38297981
FGFR2 rearrange	cholangiocarcinoma	sensitive	FGFR Inhibitor (Pan)	Erdafitinib	Case Reports/Case Series	Actionable	In a Phase II trial, Balversa (erdafitinib) treatment resulted in a confirmed objective response rate (ORR) of 40.9% (9/22, 1 complete, 8 partial responses), a median progression-free survival of 5.6 months, and median overall survival of 25.8 months in patients with cholangiocarcinoma harboring an FGFR rearrangement or FGFR short variant, with an ORR of 57.1% (8/14) with FGFR rearrangement and 12.5% (1/8) with FGFR short variant (PMID: 39138436; NCT02699606).	39138436

Showing 1 to 14 of 14 entries

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