Thursday, April 21, 2022

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.



Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...