Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has given futibatinib conditional market authorization as a monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or rearrangement that have progressed after at least one line of prior systemic therapy.

This is written in the approval document as:

Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Citation

Taiho Pharma Netherlands B.V. Lytgobi (futibatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lytgobi-epar-product-information_en.pdf. Revised October 2023. Accessed March 19, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	FGFR2 rearrangements	Cholangiocarcinoma	Futibatinib
EMA (1)	FGFR2::v	Cholangiocarcinoma	Futibatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2023-07-04	European Medicines Agency	Indication received approval from the European Commission.