Pemigatinib (Pemazyre®) – Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy

1. Characteristics

Start date 15.04.2021
Resolution 07.10.2021
INN Pemigatinib
Brand name Pemazyre®
Company Incyte Biosciences Germany GmbH
G-BA procedure ID 2021-04-15-D-670
ATC code L01EX20
Therapeutic area Oncological diseases ORPHAN
Reason for procedure New INN
Regulatory status Conditional Approval

Indication (German)

Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Subgroup Indication Comparator
Erwachsene mit lokal fortgeschrittenem oder metastasiertem Cholangiokarzinom mit einer Fibroblasten-Wachstumsfaktor-Rezeptor-2 (fibroblast growth factor receptor 2, FGFR2)-Fusion oder einem FGFR2-Rearrangement, das nach mindestens einer vorherigen systemischen Therapielinie fortgeschritten ist Nicht zutreffend

9. Associated procedures

Resolution INN Brand name Indication Additional benefit
Pemigatinib Pemazyre® Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy


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