posted on 2020-03-12, 18:28authored bySheridan M. Hoy
Compliance with Ethical Standards
Disclosure: The preparation of this review was not supported by any external funding.
Conflict of interest: During the peer review process the manufacturer of the agent under
review was offered an opportunity to comment on the article. Changes resulting
from any comments received were made by the authors on the basis of scientific
completeness and accuracy. Sheridan Hoy is a salaried employee of Adis International Ltd/Springer
Nature, is responsible for
the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug
Review can be found here.
Abstract
Tazemetostat
(Tazverik™), a first-in-class, small molecule enhancer of zeste homolog 2
(EZH2) inhibitor, received accelerated approval in January 2020 in the USA for
the treatment of adults and adolescents aged ≥ 16 years with locally
advanced or metastatic epithelioid sarcoma not eligible for complete resection.
Developed by Epizyme,
in collaboration with Eisai,
it is the first therapy to be approved specifically for the treatment of
epithelioid sarcoma in the USA. The recommended dosage regimen is 800 mg twice daily,
administered orally
with or without food, until disease
progression or unacceptable toxicity. Tazemetostat is also
undergoing clinical development in various countries worldwide for use in
several other tumour types, including diffuse large B-cell lymphoma and mesothelioma, with the US FDA
accepting a
New Drug Application and granting priority review for its use in the treatment
of follicular lymphoma. This article summarizes the milestones in the
development of tazemetostat leading to this first approval for the treatment of
adults and adolescents aged ≥ 16 years with locally advanced or metastatic
epithelioid sarcoma not eligible for complete resection.