See the DrugPatentWatch profile for Infigratinib
What is infigratinib, and what does it treat?
Infigratinib (trademark label name only varies by country) is a targeted cancer medicine that blocks signaling from certain fibroblast growth factor receptors (FGFRs), especially FGFR1–3. It is used for people with specific, FGFR-altered cancers, most notably previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other FGFR2 rearrangements in settings where the relevant biomarker test is positive and prior therapy has been given [1].
How does infigratinib work?
Infigratinib is an oral FGFR inhibitor. By blocking FGFR signaling, it can slow tumor growth driven by FGFR pathway activation from gene fusions/rearrangements [1].
Who is eligible—what biomarkers and prior treatments matter?
Eligibility depends on the cancer type and biomarker status. For cholangiocarcinoma, use is tied to identifying FGFR2 fusions/rearrangements through an approved/validated test, along with disease stage (unresectable locally advanced or metastatic) and prior treatment status as specified by the local prescribing information and regulatory approval [1].
How is it taken, and what should patients expect at the start?
Infigratinib is taken by mouth. Exact dosing schedules and dose modifications depend on the prescribing information for the patient’s regimen and tolerance [1].
What side effects are people most concerned about?
Common adverse effects reported for FGFR inhibitors like infigratinib include problems related to FGFR signaling such as eye/vision effects and changes in phosphate levels (because FGFR affects phosphate metabolism). Other side effects can include fatigue, gastrointestinal symptoms, skin/nail effects, and liver enzyme elevations depending on the individual and dose [1].
What eye or vision risks should be watched for?
With FGFR inhibitors, clinicians typically monitor for visual symptoms and may recommend prompt evaluation if patients notice changes in vision. The specific monitoring and management plan is set out in prescribing information and clinical guidance [1].
How is response measured?
For advanced cancers, response is generally assessed using imaging-based tumor response criteria used in clinical practice and trials (for example, changes in tumor size over time), alongside symptom and overall clinical status [1].
How do clinicians choose between infigratinib and other FGFR-targeted options?
Choice depends on which FGFR alteration is present, prior therapies, and local approval/availability of alternatives for the same biomarker-defined population. In cholangiocarcinoma with FGFR2 fusions/rearrangements, other FGFR inhibitors may be considered depending on the regulatory environment and treatment line [1].
Where does infigratinib fit in treatment after failure of chemotherapy?
In cholangiocarcinoma, infigratinib is typically positioned for patients who have already received prior systemic therapy and whose tumor has FGFR2 fusions/rearrangements, reflecting its targeted mechanism rather than a first-line universal approach [1].
What evidence supports infigratinib?
Approval and clinical use have been supported by trials in biomarker-selected patients with cholangiocarcinoma and FGFR2 fusions/rearrangements, showing measurable response rates and durable benefit in a subset of patients [1].
How much does it cost?
Pricing varies widely by country, insurer/health system, and treatment setting, and can change over time. Local reimbursement and patient assistance programs are often required for out-of-pocket cost estimates.
What else should be checked before starting treatment?
Clinicians generally verify:
- FGFR2 fusion/rearrangement status using an appropriate test [1]
- baseline organ function and lab parameters that can be affected by FGFR inhibition
- risk factors relevant to monitoring (including possible visual effects) [1]
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Sources
[1] https://www.cancer.gov/publications/dictionaries/cancer-drug/def/infigratinib