培美替尼适应症?

Drug indications

(Pemigatinib) is mainly used clinically to treat unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma, as well as myeloid or lymphoid tumors with FGFR rearrangements.

Pemigatinib, a small molecule inhibitor of fibroblast growth factor receptor (FGFR) 1, FGFR2 and FGFR3, received accelerated approval in the United States in April 2020 for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma and FGFR2 fusions or other rearrangements. Developed by Incyte, it is the first targeted therapy drug for cholangiocarcinoma in the United States.

Pemigatinib received orphan drug designation in the United States in August 2019 for the treatment of myeloid/lymphoid neoplasms associated with eosinophilia and PDGFRA, PDGFRB, or FGFR1 rearrangements or PCM1-JAK2.

Pemigatinib is under regulatory evaluation in the EU as a treatment for adults with locally advanced or metastatic cholangiocarcinoma and FGFR2 fusions or rearrangements who have relapsed or refractory after ≥1 line of systemic therapy. Pemigatinib is also in clinical development in multiple countries around the world for the treatment of several other FGFR-driven malignancies (such as solid tumors, urothelial cancer).

The recommended dose of pemigatinib is 13.5 mg orally administered once daily on days 1-14 of a 21-day cycle with or without food until disease progression or unacceptable toxicity.

According to research data, the clinical efficacy of pemigatinib, a targeted drug for intrahepatic cholangiocarcinoma, can reach 35.5%, and the disease control rate can reach about 82%. The median duration of response was about 9.1 months, with 63% of patients taking the drug 6 months or more and 18% of patients taking it 12 months or more.

In summary, pemigatinib, as a new anti-intrahepatic cholangiocarcinoma drug, is of great significance in the treatment of intrahepatic cholangiocarcinoma.

References

Subbiah V, Iannotti NO, Gutierrez M, Smith DC, Féliz L, Lihou CF, Tian C, Silverman IM, Ji T, Saleh M. FIGHT-101, a first-in-human study of potent and selective FGFR 1-3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies. Ann Oncol. 2022 May;33(5):522-533. doi: 10.1016/j.annonc.2022.02.001. Epub 2022 Feb 14. PMID: 35176457.