Name: Lirafugratinib (Lyrfigtu) in Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma: Ongoing post-approval monitoring
Published: 2026-09-27T09:44:05-04:00

Product information and disease description Place of product in therapy Approaches to treatment

Ongoing post-approval monitoring

4 evidence topics · 5 sources

Basis for requiring a clinical trial to assess serious risks

“known serious risks of severe stomatitis, palmar-plantar erythrodysesthesia syndrome, retinal pigment epithelial detachment, and nail toxicities; and to assess a signal of a serious risk of increased drug toxicity when lirafugratinib is used concomitantly with sensitive P-gp and BCRP substrates.” (opens the source at this quote in a new tab)
“Finally, we have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess these serious risks.” (opens the source at this quote in a new tab)

Periodic status reporting and investigational new drug application

“requires you to report annually on the status of any postmarketing commitments or required studies or clinical trials.” (opens the source at this quote in a new tab)
“Submit clinical protocol(s) to your IND 147405 with a cross-reference letter to this NDA.” (opens the source at this quote in a new tab)

Ongoing clinical study of lirafugratinib after approval

“Elevar is also conducting ReFocus202, a global Phase 2 study evaluating lirafugratinib in patients with various solid tumors harboring FGFR2 fusions or rearrangements. Patient enrollment and dosing are currently underway at clinical sites globally, including in the EU, U.K., Korea and U.S.” (opens the source at this quote in a new tab)

Adverse event reporting

“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.” (opens the source at this quote in a new tab)

Confirmatory trial registration

No evidence found.