Pemazyre

pemigatinib

Table of contents

Opinion

On 28 January 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Pemazyre2, intended for the second-line treatment of advanced or metastatic cholangiocarcinoma characterized by fusion or rearrangements of fibroblast growth factor receptor 2. The applicant for this medicinal product is Incyte Biosciences Distribution B.V.

Pemazyre will be available as 4.5 mg, 9 mg and 13.5 mg tablets. The active substance of Pemazyre is pemigatinib, a protein kinase inhibitor (ATC code: L01EX20) which is a kinase inhibitor of FGFR 1, 2 and 3 that inhibits FGFR phosphorylation and signalling and decreases viability of cells expressing FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements.

The benefits with Pemazyre are its ability to increase the number of patients with a complete or partial response after first-line treatment, which is maintained for a median of 8 months.

The most common side effects are hyperphosphatemia, alopecia, diarrhoea, nail toxicity, fatigue, nausea, dysgeusia, stomatitis, constipation, dry mouth, dry eye, arthralgia, hypophosphataemia, dry skin and palmar-plantar erythrodysaesthesia syndrome.

The full indication is:

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 therapy3.

Pemazyre should be prescribed by physicians experienced in the diagnosis and treatment of patients with biliary tract cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

2 This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

3 This document was updated to reflect changes to the text of the indication for Pemazyre adopted by CHMP on 25 February 2021

Key facts

Name
Pemazyre
Agency product number
EMEA/H/C/005266
International non-proprietary name (INN) or common name
  • pemigatinib
Active substance
  • pemigatinib
Therapeutic area
Cholangiocarcinoma
Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
28/01/2021
Company name
Incyte Biosciences Distribution B.V.
Status
Positive
Application type
Initial authorisation

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