Advanced Cholangiocarcinoma Treatment Infigratinib Granted Accelerated Approval by FDA

According to a recent article at Pharmacy Times, Infigratinib has been granted accelerated approval for the treatment of those with metastatic cholangiocarcinoma. The treatment is for adults whose cholangiocarcinoma is unresectable and locally advanced, with a fibroblast growth factor 2 fusion or another arrangement.


Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile. Bile ducts connect the liver to the gallbladder and small intestine. This condition, also known as bile duct cancer, is an uncommon form of cancer that occurs mostly in people older than age 50, though it can occur at any age.

Signs and symptoms of cholangiocarcinoma include:

  • Yellowing of your skin and the whites of your eyes (jaundice)
  • Intensely itchy skin
  • White-colored stools
  • Fatigue
  • Abdominal pain
  • Unintended weight loss


108 patients participated in the multicenter, open-label, single-arm phase 2 trial. Participants had previously undergone treatment for their unresectable cholangiocarcinoma. Each patient received 125mg of Infigratinib daily for 21 days in a row, in 28-day cycles until there was disease progression or unacceptable toxicity.

At its conclusion, the trial yielded an overall response rate (ORR) of 23%. There was 1 complete response and 24 partial responses. Furthermore, the duration of response (DoR) was on average five months.


Infigratinib is an oral kinase inhibitor. It is an inhibitor of the fibroblast growth factor receptors FGFR1, FGFR2, and FGFR3 in adult patients. It is used as a treatment for previously treated, unresectable locally advanced, or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor II (FGFR2) fusion.

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