CHMP recommends marketing authorisation for Incyte’s pemigatinib
pharmafile | February 3, 2021 | News story | Research and Development | EMA, Incyte
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the conditional marketing authorisation of Incyte’s pemigatinib for the treatment of adults with unresectable 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.
The positive opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.
The CHMP’s recommendation for the use of pemigatinib is now being reviewed by the European Commission (EC), and if approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor (FGFR2) fusion or rearrangement. The drug would be commercialised under the brand name Pemazyre.
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) 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. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 and 8,000. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10% to 16% of patients.
Dr Peter Langmuir, Group Vice President of Oncology Targeted Therapeutics at Incyte, said: “The positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying patients during the early disease stages.
“Following the recent FDA approval of pemigatinib (Pemazyre), we are delighted to be closer to offering the first targeted therapy in Europe to benefit these patients.”
Darcy Jimenez
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera
Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence …
Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amyloidosis
Wainzua (eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the European …
