Selective FGFR inhibition

Infigratinib (BGJ398) is an investigational, orally administered FGFR1-3 tyrosine kinase inhibitor in development for the treatment of patients with FGFR-driven diseases, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (bladder cancer), and achondroplasia.1-3

Because infigratinib sparingly inhibits FGFR4, patients may tolerate it better than pan–FGFR1-4 inhibitors. Infigratinib is not chemotherapy.

QED Therapeutics holds worldwide rights to infigratinib to evaluate its safety and efficacy for multiple FGFR-driven diseases.

Infigratinib clinical trials are currently enrolling, including the PROOF Trial for treatment of advanced/metastatic inoperable cholangiocarcinoma with FGFR2 fusions

For more information, email

Compassionate Use and Expanded Access

Currently, QED Therapeutics does not have a formal expanded access program in place and considers requests for expanded access only on a case-by-case basis. Inquiries regarding expanded access may be sent to You can expect acknowledgment of your message within 5 business days.

Patients seeking to enroll in clinical studies should visit for information regarding ongoing studies and current study site locations.

FGFR=fibroblast growth factor receptor.

Infigratinib Clinical Development

Second-line Therapy Cholangiocarcinoma (Bile Duct Cancer)* Urothelial Carcinoma (Bladder Cancer) Proof of Concept Phase 1 Phase 2 Phase 3 Achondroplasia First-line Therapy Cholangiocarcinoma (Bile Duct Cancer) Observational trial planned for 2019; Phase 1/2 trial to follow Planned for 2019 Currently enrolling Currently enrolling Currently enrolling *Pivotal Phase 2 Trial.

QED is currently enrolling patients for 2 clinical trials

Phase 2, Second-line Trial for Cholangiocarcinoma

*Amended Cohorts of the Second-line Trial

  • Cohort 1: patients with FGFR2 gene fusions or translocations
  • Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations
  • Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR inhibitor

All patients will receive oral infigratinib, once daily, on a schedule of 3 weeks on (21 days), 1 week off (7 days). One treatment cycle consists of 28 days.

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Phase 3, First-line Trial for Cholangiocarcinoma

PROOF Trial right arrow

QED is currently enrolling for the PROOF Trial of infigratinib for treatment of advanced/metastatic inoperable cholangiocarcinoma with FGFR2 fusions.

FGFR=fibroblast growth factor receptor.

The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.

Targeting FGFR

Genetic aberrations (eg, fusions/translocations, mutations, and amplifications) involving fibroblast growth factor receptors (FGFRs) are thought to drive disease in more than 100,000 new diagnoses each year in the United States.4,5

FGFR genetic aberrations occur in approximately 7% of cancers, most notably cholangiocarcinoma (bile duct cancer) and urothelial carcinoma (bladder cancer).5 FGFR2 genetic aberrations are present in approximately 20% of cholangiocarcinomas,6-9 and FGFR3 genetic aberrations are present in up to 20% of advanced urothelial carcinomas.10 Additionally, FGFR3 aberrations cause more than 99% of achondroplasia cases.11

Our research supports the development of infigratinib, an innovative investigational therapy that targets FGFR1-3 genetic aberrations.12 Infigratinib is currently being studied for cholangiocarcinoma (bile duct cancer), urothelial carcinoma (bladder cancer), and achondroplasia.1-3


  1. National Institutes of Health. BGJ398 in non-muscle-invasive urothelial carcinoma of the bladder. Accessed October 29, 2018.
  2. National Institutes of Health. A phase II, single arm study of BGJ398 in patients with advanced cholangiocarcinoma. Accessed October 29, 2018.
  3. Komla-Ebri D, Dambroise E, Kramer I, et al. Tyrosine kinase inhibitor NVP-BGJ398 functionally improves FGFR3-related dwarfism in mouse model. J Clin Invest. 2016;126(5):1871-1884.
  4. National Cancer Institute. Cancer statistics. Updated April 27, 2018. Accessed December 3, 2018.
  5. Helsten T, Elkin S, Arthur E, Tomson BN, Carter J, Kurzrock R. The FGFR landscape in cancer: analysis of 4,853 tumors by next-generation sequencing. Clin Cancer Res. 2016;22(1):259-267.
  6. Jain A, Borad MJ, Kelley RK, et al. Cholangiocarcinoma with FGFR genetic aberrations: a unique clinical phenotype. JCO Precis Oncol. Published online January 17, 2018. doi:1200/PO.17.00080.
  1. Farshidfar F, Zheng S, Gingras MC, et al. Integrative genomic analysis of cholangiocarcinoma identifies distinct IDH-mutant molecular profiles. Cell Rep. 2017;18(11):2780-2794.
  2. Graham RP, Barr Fritcher EG, Pestova E, et al. Fibroblast growth factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Hum Pathol. 2014;45(8):1630-1638.
  3. Sia D, Losic B, Moeini A, et al. Massive parallel sequencing uncovers actionable FGFR2-PPHLN1 fusion and ARAF mutations in intrahepatic cholangiocarcinoma. Nat Commun. 2015;6:6087. doi:10.1038/ncomms7087.
  4. Knowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015;15(1):25-41.
  5. National Institutes of Health. Genetics Home Reference. FGFR3 gene: fibroblast growth factor receptor 3. Published November 27, 2018. Accessed December 3, 2018.
  6. Javle M, Kelley RK, Roychowdhury S, et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions. Poster presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany.
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