Regulatory approval

Published by the European Medicines Agency.

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.

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