Tibsovo may be prescribed at general hospitals in KOR

A targeted anticancer therapy for cholangiocarcinoma

Passes drug committee (DC) review at the ‘Big 5’ medical institutions, including Seoul National University Hospital

Anticipation rises on its insurance reimbursement following approval by the Cancer Disease Review Committee

Tibsovo, a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia, can now be prescribed at general hospitals in Korea.

 

According to industry sources, Servier Korea’s IDH1 (isocitrate dehydrogenase 1) genetic mutation targeting therapy Tibsovo (ivosidenib) recently passed the Drug Committee (DC) review of the ‘Big 5’ tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St.

 

Mary's Hospital, and Sinchon Severance Hospital, as well as other medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital.

 

The company has been steadily expanding its prescription area since it received approval from the Ministry of Food and Drug Safety in May last year and officially launched the drug in September of the same year.

 

In addition, as the drug’s indication for cholangiocarcinoma has recently been approved by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service, expectations are rising for its reimbursement.

 

The drug is indicated for use ▲= in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation in adults aged ≥75 years with comorbidities that preclude the use of intensive induction chemotherapy, or ▲as monotherapy for locally advanced or metastatic cholangiocarcinoma in previously treated adults with IDH1 mutation.

 

Cholangiocarcinoma is a highly aggressive cancer with a poor prognosis, with a 5-year relative survival rate of just 28.9%.

 

In particular, 65% of patients with intrahepatic cholangiocarcinoma are diagnosed at an advanced stage where surgery is not feasible.

 

Tibsovo is the only targeted therapy recommended by the National Comprehensive Cancer Network (NCCN) in the highest category (Category 1) as a second-line treatment for bile duct cancer.

 

According to the Phase III ClarlDHy trial, Tibsovo reduced the risk of disease progression by 63% compared to placebo, with a median progression-free survival (PFS) of 2.7 months (1.4 months in the placebo group).

 

Additionally, the median overall survival (mOS) was 10.3 months in the Tibsovo group, more than twice as long as the 5.1 months in the placebo group.

 

Do-Youn Oh, Professor of Hematology-Oncology at Seoul National University Hospital, stated, “The development of drugs for cholangiocarcinoma has accelerated significantly in recent years.

 

As new drugs are being developed, many companies are also actively working on the development of treatments for cholangiocarcinoma.

 

It is crucial for patients with cholangiocarcinoma to follow the doctors’ guidance and receive appropriate treatment rather than be discouraged, so they can participate in clinical trials and gain access to new treatment opportunities.” Meanwhile, in the Phase III AGILE study that enrolled patients with acute myeloid leukemia, Tibsovo demonstrated improved event-free survival (EFS) when used in combination with azacitidine, and also significantly improved overall survival (OS).

 

The median OS in the Tibsovo-treated group was 24.0 months (7.9 months in the placebo group), and long-term follow-up results showed that the median OS with Tibsovo combination therapy was 29.3 months, over 3.7 times longer than with placebo combination therapy.