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Lirafugratinib (Lyrfigtu)

Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma

Also known as RLY-4008
Regulatory submission
NDA submitted January 2026
Last updated
158 sources

Company-reported prevalence

Lirafugratinib

Overview

FieldValue
DrugLyrfigtu (lirafugratinib)
IndicationPreviously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma
DiseaseCholangiocarcinoma (bile duct cancer); FGFR2-mediated or FGFR2-altered cancers across tumor types
CompanyElevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. (exclusive worldwide development and commercialization license since December 2024); Relay Therapeutics, Inc. (originator and licensor, eligible for milestones and royalties)
Documents searchedElevar Therapeutics website: home, pipeline, lirafugratinib, and investors pages (accessed October 2026); Elevar Therapeutics press releases dated December 3, 2024, January 28, 2026, March 30, 2026, June 22, 2026, July 27, 2026, September 15, 2026, September 22, 2026, and September 23, 2026; Lyrfigtu product website (access refused to scripted requests, October 2026); Relay Therapeutics Form 10-K for 2021 (February 2022), 2022 (February 2023), 2023 (February 2024), 2024 (February 2025), and 2025 (February 2026); Relay Therapeutics annual report to shareholders (April 2024); Relay Therapeutics Form 10-Q for the second quarter of 2026 (August 2026); Relay Therapeutics press release on ESMO 2022 data (September 2022); SEC full-text search of Relay Therapeutics filings for "late-line patients" (2020 to 2026); Relay Therapeutics investor events page (access refused to scripted requests, October 2026)
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Incidence: Elevar Therapeutics press release, September 2026

“CCA, also known as bile duct cancer, is diagnosed in about 8,000 people in the U.S. each year” (opens the source at this quote in a new tab)

“CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. newly diagnosed each year, according to the American Cancer Society.” (opens the source at this quote in a new tab)

Cited source: 2.1 American Cancer Society 2024

Elevar Therapeutics (2026) press release, September 23, 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Incidence (FGFR2-altered cancers across tumor types): Elevar Therapeutics website, October 2026

“FGFR2 alterations represent approximately 11k-35k patients in the United States per year across several tumor types. Additionally, FGFR2-activating fusions are particularly common in intrahepatic CCA.” (opens the source at this quote in a new tab)

Cited source: 2.2 Elevar Therapeutics 2025; 2.3 Cleary 2021; 2.4 Krook 2021; 2.5 Schönherr 2024

Elevar Therapeutics (2026) lirafugratinib website page, quoted passage highlighted (opens the full-size image in a new tab)
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Eligible population (late-line FGFR2-mediated cancers, all tumor types): Relay Therapeutics Form 10-K for 2023, February 2024

“We believe FGFR2-mediated cancers affect approximately 11,000 late-line patients annually in the United States.” (opens the source at this quote in a new tab)

“These numbers reflect the inclusion of patients with additional FGFR2 gene fusions and rearrangements that result from truncation of the protein at exon 18 based on recently published research suggesting that patients with these truncations should be considered for FGFR-targeted therapies.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Relay Therapeutics (2024) Form 10-K for 2023, quoted passage highlighted (opens the full-size image in a new tab)
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Eligible population (FGFR2-mediated cancers in earlier lines of treatment, all tumor types): Relay Therapeutics Form 10-K for 2023, February 2024

“In the future, if lirafugratinib advances to earlier lines of treatment, we believe it could potentially address approximately 35,000 patients annually in the United States.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Relay Therapeutics (2024) Form 10-K for 2023, quoted passage highlighted (opens the full-size image in a new tab)
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Eligible population (late-line FGFR2-mediated cancers, all tumor types): Relay Therapeutics Form 10-K for 2021, February 2022

“We believe FGFR2-mediated cancers affect approximately 8,000 late-line patients annually in the United States.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Relay Therapeutics (2022) Form 10-K for 2021, quoted passage highlighted (opens the full-size image in a new tab)
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Eligible population (FGFR2-mediated cancers in earlier lines of treatment, all tumor types): Relay Therapeutics Form 10-K for 2021, February 2022

“we believe it could potentially address approximately 20,000 patients annually in the United States.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Relay Therapeutics (2022) Form 10-K for 2021, quoted passage highlighted (opens the full-size image in a new tab)
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Europe

No evidence found.

Global

No evidence found.

Other countries and regions

No evidence found.

Geography not stated

No evidence found.

Sources the company cites

American cancer society 2024

Reference as the company lists it

“according to the American Cancer Society.” (opens the source at this quote in a new tab)

Elevar Therapeutics (2026) press release, September 23, 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Passage carrying the figure

“Bile duct cancer (cholangiocarcinoma) is rare. About 8,000 people in the United States are diagnosed with it each year. This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) bile duct cancers.” (opens the source at this quote in a new tab)

American Cancer Society (2024) Key Statistics for Bile Duct Cancer, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Elevar therapeutics 2025

Reference as the company lists it

“Data on file. Elevar Therapeutics; 2025.” (opens the source at this quote in a new tab)

Elevar Therapeutics (2026) lirafugratinib website page, quoted passage highlighted (opens the full-size image in a new tab)
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Passage carrying the figure

Not quoted: Internal company data on file; no published document or address.

Cleary 2021

Reference as the company lists it

“Cleary JM, et al. Cancer Discov. 2021;11(10):2488-2505.” (opens the source at this quote in a new tab)

Elevar Therapeutics (2026) lirafugratinib website page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Passage carrying the nearest figure

“As expected, several alterations that predict sensitivity to targeted therapies were enriched within IHCC patients, including FGFR2 rearrangements (12%) and mutations in IDH1 (19%), IDH2 (5%), and BRAF (3%)” (opens the source at this quote in a new tab)

Cleary 2021, quoted passage highlighted (opens the full-size image in a new tab)
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Krook 2021

Reference as the company lists it

“Krook MA, et al. Br J Cancer. 2021;124(5):880-892.” (opens the source at this quote in a new tab)

Elevar Therapeutics (2026) lirafugratinib website page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Passage carrying the nearest figure

“Fibroblast growth factor receptors (FGFRs) are aberrantly activated through single-nucleotide variants, gene fusions and copy number amplifications in 5–10% of all human cancers, although this frequency increases to 10–30% in urothelial carcinoma and intrahepatic cholangiocarcinoma.” (opens the source at this quote in a new tab)

Krook 2021, quoted passage highlighted (opens the full-size image in a new tab)
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Schönherr 2024

Reference as the company lists it

“Schönherr H, et al. Proc Natl Acad Sci U S A. 2024;121(6):e2317756121.” (opens the source at this quote in a new tab)

Elevar Therapeutics (2026) lirafugratinib website page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Passage carrying the nearest figure

“FGFR2 fusions occur in 10 to 15% of iCCA” (opens the source at this quote in a new tab)

Schönherr 2024, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

References

  1. American Cancer Society (2024) Key Statistics for Bile Duct Cancer (opens in a new tab)
  2. Cleary 2021 (opens in a new tab)
  3. Elevar Therapeutics (2026) lirafugratinib website page (opens in a new tab)
  4. Elevar Therapeutics (2026) press release, September 23, 2026 (opens in a new tab)
  5. Krook 2021 (opens in a new tab)
  6. Relay Therapeutics (2022) Form 10-K for 2021 (opens in a new tab)
  7. Relay Therapeutics (2024) Form 10-K for 2023 (opens in a new tab)
  8. Schönherr 2024 (opens in a new tab)