Scemblix may be prescribed at Big 5 Hospitals in KOR

new chronic myeloid leukemia drug

Lands at major medical institutions in Korea including SMC and SNUH

Achieves MMR 25% at Phase III ASCEMBL trial

The next-generation chronic myeloid leukemia drug ‘Scemblix’ can now be prescribed at general hospitals in Korea.

 

According to the industry sources, Novartis Korea's Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) treatment ‘Scemblix (asciminib)' has passed the drug committees of the Big 5 tertiary hospitals in Korea- Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary’s Hospital, Asan Medical Center, Sinchon Severance Hospital – as well as major medical institutions nationwide.

 

As the drug was listed for reimbursement in June, the prescription environment seems to have been created quite quickly.

 

Scemblix is reimbursed as a treatment for patients aged 18 and older with Ph+ CML in the chronic phase who are resistant or intolerant to two or more prior tyrosine kinase inhibitors (TKIs).

 

However, Scemblix is only allowed reimbursed for patients without the T315I or V299L mutations in Korea.

 

Meanwhile, Scemblix was approved in June last year as a treatment for adult patients with Ph+ CML in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs).

 

Chronic myeloid leukemia is a malignant blood disorder that occurs when myeloid cells produce white blood cells.

 

Although it progresses slowly, if left untreated, it can gradually progress to acute leukemia, and result in spleen enlargement and frequent infections as well as bleeding.

 

Currently, TKIs are used to treat patients with chronic myeloid leukemia, but treatment may be limited due to intolerance or resistance, and the longer the treatment period, the higher the failure rate.

 

Research results show that up to 70% of patients treated in the second line did not achieve major molecular response (MMR) within 2 years.

 

Contrary to existing TKIs that had the potential to develop resistance due to mutations in the ATP binding site, Scemblix specifically binds to the ABL1 myristoyl pocket to overcome mutations at the defective BCR::ABL1 gene, which is associated with the over-production of leukemic cells., and is also called the STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor.

 

Through the mechanism of action, it shows high specificity for BRC-ABL1 and is unlikely to cause resistance due to mutations in the BCR-ABL1 gene, which is associated with resistance and intolerance in patients with chronic myeloid leukemia that used to occur with existing treatments.

 

Meanwhile, Scemblix demonstrated its efficacy through the Phase III ASCEMBL study, which confirmed its clinical utility and safety profile in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who received at least two or more TKI treatments.

 

Study results showed that Scemblix improved the rate of major molecular response (MMR) compared to its comparator bosutinib by 2 times.

 

Also, the rate of treatment discontinuation due to adverse reactions in the Scemblix group was 5.8%, about one-fourth of the control group's 21.1%, confirming its overall safety profile.