Lytgobi (futibatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FGFR2::v	Intrahepatic Cholangiocarcinoma	Futibatinib
Sensitivity (+)	FGFR2 rearrangements	Intrahepatic Cholangiocarcinoma	Futibatinib