Pemazyre pemigatinib

Drug Class

FGFR inhibitor

Mechanism

Selectively inhibits FGFR1, 2, and 3 phosphorylation and downstream signaling pathways, suppressing cell proliferation in tumors harboring FGFR alterations.

Approved Indication

FDA-approved for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

What This Means For Patients

Pemazyre is a targeted FGFR kinase inhibitor. Approved by the FDA and EMA for advanced biliary tract cancer harboring FGFR2 fusions, it is accessible to patients inside Hainan Boao Lecheng.

Regulatory Approvals

• FDA — approved (2020) — label
• EMA — approved (2021) — source

Pivotal Clinical Evidence

• FIGHT-202 — Abou-Alfa et al., Lancet Oncol 2020 (NCT02924376) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/pemazyre