Monday, July 5, 2021

Inctye’s Pemazyre authorised in the EU for bile duct cancer

The European Commission (EC) has approved Incyte’s kinase inhibitor Pemazyre for the treatment of certain patients with advanced cholangiocarcinoma, also known as bile duct cancer.

Pemazyre (pemigatinib) has been granted a conditional authorisation 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 therapy.

The approval is based on data from the FIGHT-202 study – interim results found that in adult patients with previously treated, locally advanced cholangiocarcinoma harbouring FGFR2 fusions or rearrangement, Pemazyre monotherapy resulted in an overall response rate (ORR) of 37% and a median duration of response of eight months.

“Pemazyre’s approval is a crucial milestone for patients with FGFR2 positive cholangiocarcinoma. It is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care,” said Hervé Hoppenot, chief executive officer of Incyte.

“We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible,” he added.

Cholangiocarcinoma is often diagnosed at a late or advanced stage, when the prognosis is poor. FGFR2 fusions or rearrangements mainly occur in patients with intrahepatic cholangiocarcinoma, which occurs in the bile duct in the liver, where they are seen in 10-16% of patients.

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