Approved pemigatinib for the treatment of adults with certain types of pretreated, advanced cholangiocarcinoma.
Pemazyre trade name.
Pemigatinib, is a protein tyrosine kinase inhibitor 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.
It works by blocking FGFR2 in tumor cells to prevent them from growing and spreading
Routes of administration-oral.
It works by blocking enzymes known as protein kinase enzymes , particularly those at fibroblast growth factor receptors (FGFRs).
FGFRs are found on the surface of cancer cells and are involved in the growth and spread of the cancer cells.
By blocking the tyrosine kinases in FGFRs, pemigatinib reduces the growth and spread of the cancer.
FIGHT-202 multicenter open-label single-arm trial that enrolled 107 participants with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement who had received prior treatment.
Participants received pemigatinib once a day for 14 consecutive days, followed by 7 days off, in 21-day cycles
The overall response rate was 36%, with 2.8% of participants having a complete response and 33% having a partial response.
24 participants (63%) had a response lasting six months or longer and seven participants (18%) had a response lasting 12 months or longer.
107 pretreated patients with locally advanced or metastatic cholangiocarcinoma and an FGFR2 fusion or rearrangement.
Overall response rate was found to be 36%, with 2.8% of patients having a complete response and 33% having a partial response.
Among the 38 responders, 24 (63%) and 7 (18%) patients had responses lasting ≥6 months and ≥12 months, respectively.
Adverse reactions were: hyperphosphatemia and hypophosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin.