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Zulassung eines Arzneimittels mit neuem Wirkstoff: Pemazyre®, Tabletten (Pemigatinibum) - Autorisation d’un médicament contenant un nouveau principe actif: Pemazyre®, comprimés (pemigatinibum)

09-08-2021 13:50

PEMAZYRE wird gemäss SWISSMEDIC und Fachinformation (Stichwort Pemazyre) als Monotherapie angewendet zur Behandlung von Erwachsenen mit lokal fortgeschrittenem, inoperablem oder metastasiertem Cholangiokarzinom mit einer Fibroblasten-Wachstumsfaktor-Rezeptor-2 (FGFR2)-Fusion oder einem FGFR2-Rearrangement, das nach mindestens einer vorgängigen systemischen Therapielinie fortgeschritten ist (siehe «Klinische Wirksamkeit»).

 

Selon SWISSMEDIC et l’information professionnelle (mot-clé Pemazyre) Pemazyre est indiqué en monothérapie pour le traitement des adultes atteints d’un cholangiocarcinome localement avancé, non résécable ou métastatique avec fusion ou réarrangement du récepteur 2 du facteur de croissance des fibroblastes (FGFR2) dont la maladie a progressé après au mois une ligne de traitement systématique (voir « Efficacité clinique »).

Info in English:

Zug, Switzerland, 22.06.2021 – Incyte, a Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs announced that Swissmedic has granted temporary authorization of PEMAZYRE® (pemigatinib) for targeted treatment of adult patients with with locally advanced, unresectable or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one line of systemic therapy.1

The approval is based on results from the pivotal Phase II FIGHT-202 study, which evaluated the efficacy and safety of PEMAZYRE® as second-line monotherapy in adult patients with progressive CCA with a FGFR2 fusion or rearrangement after at least one line of systemic therapy.2

PEMAZYRE® is administered once-daily as one 13,5 mg tablet.1

The approval in Switzerland follows the approval in the U.S. in 2020, where many patients are already benefiting from this new treatment option. A Marketing Authorization Application for PEMAZYRE® for a similar indication was validated by the European Medicines Agency in March 2020.

About Cholangiocarcinoma

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor3,4. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,0005,6. FGFR2 fusions or rearrangements occur almost exclusively in intrahepatic cholangiocarcinoma, where they are observed in 10-16 percent of patients7,8,9.

About PEMAZYRE® (pemigatinib)

PEMAZYRE® is a potent, selective inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. PEMAZYRE® was discovered and developed in-house at Incyte, Wilmington, Delaware.

For more information about PEMAZYRE®, please see full Prescribing Information.1

1 https://www.swissmedicinfo.ch/

2 Abou-Alfa, Ghassan K et al. The Lancet Oncology, Volume 21, Issue 5, 671 – 684

3 Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261‒280.

4 Uhlig J, et al. Ann Surg Oncol. 2019;26:1993–2000.

5 Kirstein MM, Vogel A. Visc Med 2016; 32: 395-400.

6 Countries factored include: UK, Germany, France, Spain, Italy, Switzerland, Denmark, Finland, Poland and Austria

7 Graham RP, et al. Hum Pathol. 2014;45:1630‒1638.

8 Ang C. J. Gastroenterol Hepatol. 2015;30:1116‒1122.

9 Ross JS et al. The Oncologist. 2014;19:235–242.

 

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