Frequently Asked Questions

PEMAZYRE contains the active substance pemigatinib, a kinase inhibitor of fibroblast growth factor receptor (FGFR) 1, 2 and 3. PEMAZYRE is only available on prescription.¹

Reference
1. PEMAZYRE^® (pemigatinib) Summary of Product Characteristics.

PEMAZYRE is available as oral tablets in the following doses:¹

• PEMAZYRE 4.5 mg tablets
• PEMAZYRE 9 mg tablets
• PEMAZYRE 13.5 mg tablets

List of excipients:¹
Microcrystalline cellulose (E-460)
Sodium starch glycolate (Type A)
Magnesium stearate (E-572)

Reference
1. PEMAZYRE^® (pemigatinib) Summary of Product Characteristics.

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 1 prior line of systemic therapy.¹

This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited. The Medicines and Healthcare products Regulatory Agency will review new information on this medicinal product at least every year and the Summary of Product Characteristics will be updated as necessary.¹

Reference
1. PEMAZYRE^® (pemigatinib) Summary of Product Characteristics.

PEMAZYRE contains the active substance pemigatinib, a kinase inhibitor of fibroblast growth factor receptor (FGFR) 1, 2 and 3. It inhibits FGFR phosphorylation and signalling and decreases cell viability in cells expressing FGFR genetic alterations, including point mutations, amplifications and fusions or rearrangements. FGFR2 fusions/rearrangements are strong oncogenic drivers and are the most common FGFR alteration occurring, almost exclusively, in 10–16% of intrahepatic cholangiocarcinoma.¹

Reference
1. PEMAZYRE^® (pemigatinib) Summary of Product Characteristics.

In March 2021, the European Commission approved PEMAZYRE 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 1 prior line of systemic therapy.¹ The decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorisation of PEMAZYRE. Marketing authorisation was granted in United Kingdom on 07 April 2021.

Reference
1. PEMAZYRE^® (pemigatinib) Summary of Product Characteristics.

The marketing authorisation holder for PEMAZYRE is:¹

United Kingdom
Incyte Biosciences UK Ltd,
First Floor Q1, The Square,
Randalls Way, Leatherhead,
KT22 7TW, UK

Republic of Ireland
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25,
1105 BP Amsterdam, Netherlands

Reference
1. PEMAZYRE^® (pemigatinib) Summary of Product Characteristics.