TAZ-DR-RD-243 Key Points Table.PNG (35.39 kB)
Tazemetostat: First Approval
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posted on 2020-03-12, 18:28 authored by Sheridan M. HoyCompliance with Ethical Standards
Disclosure: The preparation of this review was not supported by any external funding.
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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.
© Springer Nature
Switzerland AG 2020