Posted by Michael Wonder on 08 Jan 2020
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for pemigatinib in patients with cholangiocarcinoma
7 January 2020 - Incyte today announced the validation of the Company’s marketing authorisation application for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.
The European Medicines Agency’s validation of the application confirms that the submission is sufficiently complete to begin the formal review process.
The application is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.
