Acute promyelocytic leukemia (APL)
Purpose of use
Tamibarotene is a therapeutic agent for treating acute promyelocytic leukemia. Toko Pharmaceutical Industrial Co., Ltd. received approval for this agent in Japan in 2005. Acute promyelocytic leukemia develops when cancerous promyelocytes proliferate. This proliferation occurs when the differentiation of promyelocytes is inhibited by the PML-RARalpha chimeric gene, which is generated by the translocation of chromosome 15 with chromosome 17. Using Tamibarotene to target this stage, it is believed that the variant property of PML-RARalpha can be canceled and that the PML and RARalpha functions can be normalized, resulting in the differentiation induction of myeloid. Tamibarotene has also been reported to be effective in the treatment of acute promyelocytic leukemia patients who have stopped responding the Tretinoin.
Tamibarotene is being jointly developed by the Company’s subsidiary GNI-EPS (HONG KONG) Holdings Limited and Toko Pharmaceutical Industrial Co., Ltd. After promising results from the import clinical trials interim analysis, it was decided to conclude the trials earlier than scheduled and an application was subsequently filed with the CFDA for approval of Tamibarotene.