23 September 2026 | U.S. FDA Regulatory Update
The U.S. Food and Drug Administration (FDA) has approved Lirafugratinib (Lyrfigtu) capsules, developed by Elevar Therapeutics Inc., under NDA 220425. The approval was issued on September 23, 2026.
Approved Indication
Lirafugratinib is approved for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
Key Regulatory Highlights
- Applicant: Elevar Therapeutics Inc.
- Product: Lyrfigtu (lirafugratinib) capsules
- NDA: 220425
- Approval Date: September 23, 2026
- Therapeutic Area: Oncology
- Indication: Previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangement
- Regulatory pathway: NDA submitted under Section 505(b) of the FD&C Act.
Postmarketing Requirements
As part of the approval, FDA has required additional postmarketing studies. These include a randomized clinical trial to further characterize serious risks and evaluate the safety and activity of the 70 mg once-daily dose versus a lower dose in the indicated patient population. FDA also requires a clinical pharmacokinetic study to evaluate potential drug interactions involving P-gp and BCRP substrates.
FDA has also established a postmarketing commitment requiring analytical and clinical validation studies supporting the use of an FDA-authorized in vitro companion diagnostic to identify patients with FGFR2 fusions or other rearrangements.
Intelligence Perspective
The approval represents a notable development in the FGFR-targeted oncology landscape, particularly for patients with FGFR2-altered cholangiocarcinoma. From a regulatory and competitive intelligence perspective, the approval also highlights the importance of biomarker identification, companion diagnostics, postmarketing safety commitments, and drug–drug interaction assessment in targeted oncology therapies.
Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220425Orig1s000ltr.pdf