Futibatinib (1) – Lytgobi®
Cholangiocarcinoma, with FGFR2 fusion or FGFR2 rearrangement, after at least 1 prior therapy
Characteristics
| Start date | 01.06.2024 – Marketing authorisation: 04.07.2023 |
|---|---|
| Resolution | 22.11.2024 |
| INN | Futibatinib |
| Brand name | Lytgobi® |
| Pharm. company | Taiho Pharma Netherlands |
| G-BA Procedure ID | D-1064 |
| ATC code | L01EN04 FGFR tyrosine kinase inhibitors (L01EN) |
| ICD-10 codes (AIS) | C22.1Intrahepatic bile duct carcinoma, C24.0Malignant neoplasm of biliary duct or passage NOS, C24.1Malignant neoplasm of ampulla of Vater, C24.8Malignant neoplasm involving both intrahepatic and extrahepatic bile ducts, C24.9Malignant neoplasm of biliary tract, unspecified |
| Alpha-ID codes (AIS) | I103101Malignant neoplasm of the bile ducts, I110602Cholangiocarcinoma, I29985Malignant neoplasm of the extrahepatic bile duct, I84940Malignant neoplasm of the ampulla hepatopancreatica, I85652Malignant neoplasm of the intra- and extrahepatic bile ducts |
| Therapeutic area | Oncological diseases Biliary tract cancer (BTC) / Cholangiocarcinoma |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
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Lytgobi is used as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or FGFR2 rearrangement that has progressed after at least one prior line of systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or FGFR2 rearrangement; after at least one prior line of systemic therapy | Pemigatinib |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (FOENIX-CCA2) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + ITC (MAIC)) |
| ACT change | 12.09.2023 – Änderung des Therapiestandards |
- Clinical trials
- The FOENIX-CCA2 trial is a single-arm, open-label, multicentre Phase I/II trial investigating the efficacy and safety of futibatinib.
- The FIGHT-202 trial is a single-arm, open-label, multicentre Phase II trial designed to investigate the efficacy and safety of pemigatinib in adults with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or -rearrangements, who have previously received treatment and have experienced disease progression.
Adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or FGFR2 rearrangement; following at least one prior line of systemic therapy
- The additional benefit is not proven.
- Therefore, the additional benefit of futibatinib as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or FGFR2 rearrangement, which has progressed following at least one prior line of systemic therapy, proof is not proven.
- To assess the additional benefit of futibatinib, the pharmaceutical manufacturer drew on the results of the single-arm FOENIX-CCA2 trial.
- The results of the single-arm study are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy.
- For an indirect comparison of treatment with futibatinib versus pemigatinib, the pharmaceutical manufacturer submitted a naive comparison as well as MAIC analyses without a bridge comparator for individual arms, based on the FOENIX-CCA2 and FIGHT-202 studies.
- MAIC analyses without a bridge comparator are not regarded as an adequate method of adjusting for confounders.
- Furthermore, conducting MAIC analyses for only one endpoint (in this case, overall survival) is also considered inappropriate.
Courtesy translation only, please refer to the German original.
Associated procedures
| Futibatinib (1) | Lytgobi® | Taiho Pharma Netherlands | Cholangiocarcinoma, with FGFR2 fusion or FGFR2 rearrangement, after at least 1 prior therapy | 27–229 | 100% additional benefit not proven |
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