Name: Lirafugratinib (Lyrfigtu) in Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma: Access and distribution
Published: 2026-09-27T09:44:05-04:00

Product information and disease description Product description Product information

Access and distribution

3 evidence topics · 6 sources

Commercial availability

“Lyrfigtu is expected to be available to patients in the U.S. by Q4 2026.” (opens the source at this quote in a new tab)

Patient support program: Elevar Care Connect

“Elevar Is Committed to Supporting Patients Throughout Their Treatment Journey With Elevar Care Connect” (opens the source at this quote in a new tab)
“Contact Elevar Care Connect at 1-833-T0GETHR (1-833-804-3847), Monday through Friday, 8AM-8PM ET” (opens the source at this quote in a new tab)

“Learn about financial support programs, including co-pay assistance and prescription assistance.” (opens the source at this quote in a new tab)

Companion diagnostic availability

“An FDA-authorized test for detection of FGFR2 gene fusions or other rearrangements in patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma for selecting patients for treatment with LYRFIGTU is not available.” (opens the prescribing information at this quote)

“For example, we have engaged Foundation Medicine, Inc. to develop its FoundationOne®CDx as a companion diagnostic for lirafugratinib.” (opens the source at this quote in a new tab)

“Conduct adequate analytical and clinical validation studies to support revisions to the labeling of lirafugratinib to specify the use of an FDA-authorized in vitro companion diagnostic device to accurately and reliably identify patients using blood and/or tissue samples who have FGFR2 fusions and other rearrangements and for whom lirafugratinib therapy is indicated.” (opens the source at this quote in a new tab)

Specialty pharmacy and distribution network

No evidence found.