MHLW (Japan) approval for Sembrix the first drug for chronic myelogenous leukemia in Japan that has a new mechanism of action and STAMP inhibitory effect. Novartis,

For the first time in Japan, Novartis obtained marketing approval for Sembrix Tablets 20 mg and 40 mg (generic name: asiminib hydrochloride) which have an inhibitory effect.

Chronic myelogenous leukemia (CML) is treated with a tyrosine kinase inhibitor (TKI), which is a molecular-targeted drug that appeared about 20 years ago. It is said to have transitioned to a chronic disease that can be controlled. On the other hand, many patients are resistant or intolerant to current CML treatments, and the challenge is that treatment options are limited for such patients.

Sembrix is a new CML treatment drug that has a different mechanism of action from conventional TKIs due to its STAMP inhibitory effect that specifically targets ABL myritoyl pockets. With this approval, Novartis will be able to offer new treatment options to patients who have been refractory or intolerant to previous TKI treatments.

Sembrix was approved based on the results of an international joint phase III validation study (ASCEMBL study) in patients who were resistant or intolerant to two or more TKIs .