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  • CPAC ¡®Scemblix¡¯s orphan drug designation is valid¡¯
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Jun 13, 2024 05:48am
Treatment for chronic myeloid leukemia
Iclusig is the only treatment available in Korea
The CPAC deems drug Scemblix¡¯s designation valid based on its improved safety and efficacy compared with its alternative
 ¡ã Pic of Scemblix
The next-generation chronic myeloid leukemia drug ¡®Scemblix (asciminib)¡¯ is expected to be available for adult patients with chronic myeloid leukemia (CML) with the T315I mutation or Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL) with the T315I mutation.

According to the minutes of the Central Pharmaceutical Affairs Council that were disclosed by the Ministry of Food and Drug Safety on the 11th, the CPAC had discussed Scemblix¡¯s orphan drug designation agenda at its last meeting.

In Korea, Scemblix is currently only approved as a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase previously treated with two or more
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