Incyte receives EC approval for Pemazyre
pharmafile | March 30, 2021 | News story | Manufacturing and Production | EU
Incyte have received approval from the European Commission (EC) for Pemazyre (pemigatinib), the first new treatment for adults with locally advanced or metastatic cholangiocarcinoma in over a decade.
Pemazyre is the first targeted therapy approved in the EU for metastatic cholangiocarcinoma patients with a fibroblast growth factor receptor 2 (FGFR2) fusion, or rearrangement that have progressed after at least one prior line of systemic therapy.
The decision follows a positive opinion received from the EMA’s Committee for Medicinal Products for Human Use in January, recommending the conditional marketing authorisation of Pemazyre.
Hervé Hoppenot, CEO of Incyte, said: “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.
“We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible.”
The EC approval was based on the successful results from the Phase II clinical trial, FIGHT-202. The study demonstrated that in patients harboring FGFR2 fusions or rearrangements, Pemazyre monotherapy resulted in an overall response rate of 37% and a median duration of response of 8 months, based on an independent central radiographic review.
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver.
Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor, and in Europe the incidence of cholangiocarcinoma ranges between 6,000 – 8,000.
Kat Jenkins
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