Truseltiq (Infigratinib) a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.
Truseltiq is sponsored by BridgeBio Pharma/QED Therapeutics and Helsinn Group.
FDA also approved FoundationOne CDx (Foundation Medicine Inc.) for selection of patients with FGFR2 fusion or other rearrangement as a companion diagnostic device for treatment with infigratinib.
Efficacy was demonstrated in CBGJ398X2204 (NCT02150967), a multicenter open-label single-arm trial, that enrolled 108 patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement as determined by local or central testing. Patients received infigratinib 125 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles until disease progression or unacceptable toxicity.
The major efficacy outcome measures were overall response rate and duration of response, as determined by blinded independent central review according to RECIST 1.1.
The ORR was 23% (95% CI: 16, 32), with one complete response and 24 partial responses. Median DoR was 5 months (95% CI: 3.7, 9.3). Among the 23 responders, eight patients maintained the response for six months or more.
Truseltiq is sponsored by QED Therapeutics Inc.
The parallel approvals of this therapy and CDx mean healthcare professionals will be able to identify cholangiocarcinoma patients with FGFR2 fusions and select rearrangements who may benefit from TRUSELTIQ, another important step in helping more advanced cancer patients benefit from precision medicine.
FoundationOne CDx is the first FDA-approved CGP test for all solid tumors that incorporates multiple CDx claims. It currently is approved as a CDx test for 26 unique therapies and is the only tissue-based CGP test approved to identify patients who may be appropriate for treatment with Truseltiq.
