Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) revealed today that it has actually gotten orphan drug classification for anticancer representative the EZH2 * 1 inhibitor tazemetostat hydrobromide (generic name, item name “Tazverik ® Tablets 200 mg”, “tazemetostat”) for unresectable INI1 * 2-negative epithelioid sarcoma that has actually advanced after chemotherapy, from the Ministry of Health, Labour and Welfare (MHLW).
Epithelioid sarcoma is a kind of soft tissue sarcoma that is an uncommon cancer approximated to represent about 1% of all soft tissue sarcoma.1 Only 174 cases were signed up from significant health centers throughout Japan over a10-year duration from 2006 to 2015.2 Loss of INI1, which is an unfavorable regulator of EZH2, is observed in over 90% of epithelioid sarcoma cases,3 causing EZH2 activation that is thought to drive growth beginning and deadly development. Treatment choices are restricted, leading to an incredibly high unmet medical requirement.
Tazemetostat was authorized in Japan in June 2021 for fallen back or refractory EZH2 gene mutation-positive follicular lymphoma (just when basic treatment is not appropriate). For INI1-negative unresectable epithelioid sarcoma that has actually advanced after chemotherapy, a Phase II investigator-initiated trial of tazemetostat (A Phase II Trial of Tazemetostat for Patients with Unresectable or Metastatic Epithelioid Sarcoma: TAZETTA trial), led by the National Cancer Center Hospital, is presently underway.
Eisai recognizes oncology as one of its top priority locations and aims to establish ground breaking brand-new treatments focused on treating cancer. We stay dedicated to fulfilling the varied requirements of cancer clients worldwide, their households, and health care specialists, and to improving the advantages provided to them.
* 1 A kind of histone methyl group elongation enzyme, it is a protein that manages gene expression by methylating the 27th lysine residue of histone H3 (H3K27).
* 2 One of the proteins that comprise the SWI/SNF chromatin complex (a protein complex that customizes chromatinstructure to control gene function), it is associated with managing gene expression.
For more information, please check out: https://www.eisai.com/news/2025/pdf/enews202558pdf.pdf
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