Primary navigation

    Truseltiq®

    Drug - Truseltiq® (infigratinib) [QED Therapeutics, Inc.]

    April 2022

    Therapeutic Area - Oncology, Oral - Other

    Initial approval criteria

    • Patient must be at least 18 years old AND

    Universal Criteria

    • Patient has received a comprehensive ophthalmic examination including optical coherence tomography at baseline and repeated periodically (months 1, 3, and every 3 months thereafter) throughout therapy AND
    • Patient serum phosphate level is measured at baseline and periodically throughout therapy AND
    • Therapy will not be used concomitantly with other selective FGFR-inhibitors (e.g., erdafitinib, pemigatinib, etc.) AND
    • Patient will not be on concomitant therapy with any of the following:
      • Acid-reducing agents (if therapy with H2-antagonists or locally acting antacids is unavoidable, stagger the administration) AND
      • Strong or moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.) AND
      • Strong or moderate CYP3A inhibitors (e.g., fluconazole, itraconazole, etc.), or if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications AND

    Cholangiocarcinoma

    • Must be used as a single agent AND
    • Patient has unresectable locally advanced or metastatic disease AND
    • Patient has a susceptible gene mutation rearrangement or fusion in the fibroblast growth factor receptor2 (FGFR2) gene, as determined by an FDA-approved or CLIA-compliant test AND
    • Used as subsequent therapy AND
    • Patient received at least one line of prior therapy which contained gemcitabine
    • Initial approval is for 6 months

    Renewal criteria

    • Patient continues to meet the universal and indication specific criteria as identified in the initial approval criteria; AND
    • Disease response with treatment defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
    • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include retinal pigment epithelial detachment (RPED), severe hyperphosphatemia, etc.; AND
    • Patient serum phosphate level is ≤7.5mg/dL
    • Renewal approval is for 6 months

    Quantity limits

    • All strengths:  1 carton per 28 days

    Background

    Truseltiq is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (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 confirmatory trial(s). 

    Questions?

    MHCP Provider Resource Center 651-431-2700 or 1-800-366-5411

    back to top