Infigratinib is a selective tyrosine kinase inhibitor (TKI) of fibroblast growth factor receptors (FGFRs).1
TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
TRUSELTIQ was studied in a phase 2, multicenter, open-label, single-arm trial of 108 adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).1,2
- Patients with CCA who have an FGFR2 fusion or other rearrangement
- ≥1 prior line of systemic therapy
- 125 mg orally, once daily
- 21 consecutive days followed by 7 days off therapy, in 28-day cycles
- Until disease progression or unacceptable toxicity
- Overall response rate (ORR)
- Duration of response (DoR)
Baseline Patient Characteristics1-3
TRUSELTIQ showed clinically meaningful efficacy in a phase 2, multicenter, open-label, single-arm trial of 108 patients with 2L+ FGFR2 fusion-driven CCA1,3
TRUSELTIQ demonstrated antitumor activity in patients with previously treated, unresectable, locally advanced or metastatic disease1,3
(95% CI: 16, 32)*
ORR=overall response rate.
(95% Cl: 4, 9)*
- 3.6 months median TTR (range 1.4-7.4)
DoR=duration of response; TTR=time to response.
Additional analyses† were conducted in the study of TRUSELTIQ1-3
Prespecified subgroup analysis
Subgroup receiving only
≤1 prior line of therapy:
(n=50; 95% CI: 21, 49)*†
2-8 prior lines of therapy:
(n=58; 95% CI: 6, 25)*†
Progressive disease, 10.2% and unknown, 5.6%.
Disease control rate (DCR) is the sum of complete response, partial response, and stable disease.
*As determined by blinded independent central review (BICR).1
‡Stable disease may be associated with the natural course of disease. The difference cannot be characterized in a single-arm study.4
Definition of prior line excludes perioperative therapies.3
Results from the prespecified subgroup analysis are limited by small sample sizes and wide confidence intervals.
†The additional analyses are consistent with labeling, but are not included in the US Prescribing Information for TRUSELTIQ.
NCCN Guidelines Recommendations
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommend infigratinib (TRUSELTIQ) as a subsequent-line treatment option for unresectable or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements following disease progression5§II¶
§See the Guidelines online at NCCN.org for the full recommendation.
IINCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
¶Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
NCCN=National Comprehensive Cancer Network.
Take a look at the TRUSELTIQ safety profile
- TRUSELTIQ Prescribing Information. Brisbane, CA: QED Therapeutics, Inc.; May 2021.
- Javle M, et al. Lancet Gastroenterol Hepatol. Published Online August 3, 2021. https://doi.org/10.1016/S2468-1253(21)00196-5.
- Data on file TRUS-003.
- Food and Drug Administration. https://www.fda.gov/media/71195/download. Accessed July 8, 2021.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers V.3.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 15, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.