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2 Information about pemigatinib

Anticipated marketing authorisation indication

2.1 On 28 January 2021 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for pemigatinib (Pemaryze, Incyte Corporation) for treating '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'.

Dosage in the marketing authorisation

2.2 The dosage schedule will be available in the summary of product characteristics.


2.3 The list price of pemigatinib is £7,159.04 for a 14-pack of 13.5 mg tablets (company submission), which equates to an annual cost of £124,430. The company has a commercial arrangement, which would have applied if the technology had been recommended.