Research & Development
Incyte's Marketing Authorisation Application for Pemigatinib receives European Medicines Agency validation
9 January 2020 -

United States-based Incyte has received European Medicines Agency (EMA) validation of its Marketing Authorisation Application (MAA) for Pemigatinib intended for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy, it was reported yesterday.

The EMA's validation of the MAA confirms that the submission is sufficiently complete to start the formal review process.

The MAA application is based on data from the FIGHT-202 study assessing the product as a treatment for patients with earlier treated, locally advanced or metastatic cholangiocarcinoma. The FIGHT-202 Phase two, open-label, multicentre study (NCT02924376) is evaluating the safety and efficacy of the product – a selective fibroblast growth factor receptor inhibitor – in adult (aged over 18 years) patients with earlier treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

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