Pemazyre lands in major hospitals in Korea

New bile duct cancer drug Pemazyre may be prescribed at major hospitals in Korea

New possibility arises in the limited bile duct cancer treatment environment

Listed for reimbursement in May... expected to prompt full-scale prescriptions

Pemazyre, a treatment for intrahepatic bile duct cancer(cholangiocarcinoma), may now be prescribed at tertiary hospitals in Korea.

 

According to industry sources, Handok's Pemazyre (pemigatinib) has passed the drug committee (DC) of the Big 5 general hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital.

 

As the drug has been listed for reimbursement starting this May, the stage has now been set for its full-scale prescription in Korea.

 

The drug is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

 

Pemazyre is the first drug in Korea to be approved for this patient population.

 

In March 2022, Handok signed an agreement with the global biopharmaceutical company Incyte Corp for the registration and supply of Pemazyre in Korea.

 

Pemazyre was designated as an orphan drug by the Ministry of Food and Drug Safety in November 2021.

 

A dire need existed in the field of cholangiocarcinoma due to the lack of a standardized second-line therapy for patients who fail first-line therapy.

 

Surgery is the best treatment for bile duct cancer, but typically only 20-30% of patients are eligible for surgery at the time of diagnosis.

 

Even after surgery, bile duct cancer has a high recurrence rate of 60-70% and a reported 5-year survival rate of less than 20%.

 

Specifically, fusions or other rearrangements of the FGFR2 gene, for which Pemazyre is indicated, occur in approximately 10-16% of patients with intrahepatic cholangiocarcinoma.

 

The approval of Pemazyre is based on the Phase II FIGHT-202 study.

 

The open-label, single-arm Phase II FIGHT-202 study enrolled 107 adult patients (mean age 56 years) who had received at least one prior therapy for locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene.

 

The results showed that the primary efficacy endpoint, objective response rate (ORR), was 35.5%, and the secondary endpoint, median duration of response (DOR), was 7.5 months in the Pemazyre arm.

 

In addition, the reported median progression-free survival (PFS) was 6.9 months, and the median overall survival (OS) was 21.1 months.

 

The most commonly reported treatment-related adverse event was hyperphosphatemia, which was of the lowest severity (Grade 1 or 2) and manageable.