On November 3, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported that lirafugratinib (Lyrfigtu) has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology1 (NCCN Guidelines) as a Category 2A (useful in certain circumstances) preferred subsequent-line therapy for disease progression in cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement.

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"The NCCN Guidelines are an important tool in helping clinicians determine the optimal treatment options for their patients," said Rose Lai, M.D., senior vice president of clinical development at Elevar Therapeutics. "We are pleased that lirafugratinib was promptly added to the guidelines upon FDA approval."

Elevar, on Sept. 23, 2026, announced the U.S. Food and Drug Administration (FDA) approval of lirafugratinib (Lyrfigtu) based on the Phase 1/2 ReFocus trial (NCT04526106), in which lirafugratinib demonstrated a confirmed objective response rate (ORR) of 46% (95% CI 36, 55), and a median duration of response of 11.8 months (95% CI 7.5, 13.0) in patients with the proposed indication. Median progression-free survival was 11.3 months (95% CI, 9.2, 14.8), with a 12-month rate of 49.2%. Its safety profile in the clinical data was shown to be manageable through dose adjustments.

Lyrfigtu is expected to be available to patients in the U.S. by Q4 2026.

Important Safety Information for LYRFIGTU (lirafugratinib)

Warnings and Precautions:

Ocular Toxicity

LYRFIGTU can cause retinal pigment epithelial detachment (RPED), which may cause symptoms such as blurred vision.

Among 385 patients who received LYRFIGTU, RPED occurred in 31% of patients, including Grade 3 events in 1.8%. The median time to first onset was 57 days. RPED led to dose interruption in 15% of patients and dose reduction in 10%.

Perform a comprehensive ophthalmological examination, including OCT of the macula, prior to initiation of therapy, every 2 months for the first 13 months, and every 4 months thereafter. For onset of visual symptoms, obtain ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYRFIGTU. Withhold, reduce the dose, or discontinue LYRFIGTU based on severity.

Among 385 patients who received LYRFIGTU, blurred vision occurred in 18% of patients with Grade 3 events in 1.3% of patients.

Dry eye occurred in 38% of patients. Treat patients with ocular demulcents as needed.

Among 385 patients who received LYRFIGTU, corneal toxicity/keratitis occurred in 11% of patients. Treat patients with ocular demulcents as needed.

Hyperphosphatemia and Soft Tissue Mineralization

LYRFIGTU can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification.

Hyperphosphatemia occurred in 21% of patients. The median time to onset was 15 days. Hyperphosphatemia led to dose interruption in one (0.3%) patient and no permanent discontinuation. Monitor serum phosphate throughout treatment and manage as clinically appropriate.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, LYRFIGTU can cause fetal harm or loss of pregnancy when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.

Contraindications:

None.

Adverse reactions:

Serious adverse reactions occurred in 32% of patients. Serious adverse reactions reported in ≥2% of patients were infection (6%), pneumonia (3.4%), fatigue (2.6%), and hemorrhage (2.6%). A fatal adverse reaction of hemorrhage occurred in one patient.

The most common adverse reactions (≥20%) were nail toxicity, palmar-plantar erythrodysesthesia syndrome, stomatitis, alopecia, dry eye, dry mouth, fatigue, dysgeusia, retinal pigment epithelial detachment, constipation, dry skin, infection, rash, abdominal pain, hemorrhage, blurred vision, diarrhea, musculoskeletal pain, nausea, and decreased appetite.

The most common laboratory abnormalities (≥20%) were increased phosphate, increased alanine aminotransferase, increased creatinine, decreased hemoglobin, decreased sodium, decreased lymphocytes, increased blood bilirubin, increased aspartate aminotransferase, decreased platelets, increased glucose, decreased leukocytes, increased alkaline phosphatase, decreased albumin, decreased phosphate, decreased neutrophils, decreased bicarbonate.

Reporting Suspected Adverse Events: To report SUSPECTED ADVERSE REACTIONS, contact Elevar Therapeutics at 1-866-4ELEVAR or contact the FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

Please see full Prescribing Information, including Patient Information, for Lyrfigtu. For more information about Elevar, visit ElevarTX.com.

About LYRFIGTU (Lirafugratinib)

Lyrfigtu (lirafugratinib, aka RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Lyrfigtu is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.

(Press release, Elevar Therapeutics, NOV 3, 2026, View Source [SID1234674121])