LYTGOBI (futibatinib) -  Cholangiocarcinoma

The Committee deems that the clinical benefit of LYTGOBI (futibatinib) 4 mg is low for the subgroup of patients with locally advanced or metastatic intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement, whose disease has progressed after at least one line of systemic treatment, and who are ineligible for FOLFOX chemotherapy, and at the MA dosage.

Within the reimbursement scope selected by the Committee:

Taking into account:

• the data from a non-comparative study, and the lack of robust data from indirect comparisons that are difficult to interpret on account of methodological weaknesses;
• the partially met medical need for cases ineligible for the FOLFOX regimen, with PEMAZYRE (pemigatinib) in particular;
• the additional toxicity in particular the incidence of grade ≥ 3 adverse events (AEs) of 76.7%. Moreover, the onset of serous retinal detachment was identified as a substantial risk in the RMP;

the Committee deems that LYTGOBI (futibatinib) 4 mg provides no clinical added value (CAV V) for the treatment of the subgroup of patients with locally advanced or metastatic intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement, whose disease has progressed after at least one line of systemic treatment, and who are ineligible for FOLFOX chemotherapy.