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TextPharmaceutical Guanlan
According to the China Drug Clinical Trial Registration and Information Publicity Platform, Epizyme has launched an international multi-center (including China) Phase 3 clinical trial of tazemetostat in the treatment of relapsed/refractory follicular lymphoma
.
According to public information, tazemetostat is a "first-in-class" EZH2 methyltransferase inhibitor developed by Epizyme.
EZH2 is a histone methyltransferase that regulates the normal physiological functions of cells by catalyzing the methylation of histone H3 lysine 27 (H3K27) to control the expression of various genes
.
EZH2 dysregulation exists in various cancers, including follicular lymphoma and diffuse large B-cell lymphoma, and is associated with poor clinical prognosis and efficacy
As an EZH2 inhibitor, tazemetostat can inhibit the methylation of H3K27 by inhibiting EZH2, restore the expression of tumor suppressor genes, and allow B cells to continue to differentiate or undergo apoptosis, thereby controlling tumor growth
.
In 2020, the drug has received accelerated approval from the FDA for the treatment of epithelioid sarcoma and relapsed/refractory (R/R) follicular lymphoma
In August 2021, Chi-Med entered into a partnership with Epizyme to acquire the development and commercialization rights of tazemetostat in Greater China (including mainland China, Hong Kong, Macau and Taiwan) for the treatment of various blood cancers and solid tumors , including epithelioid sarcoma, follicular lymphoma, and diffuse large B-cell lymphoma
.
According to the cooperation, Chi-Med will also participate in the global registration study (EZH-302 study) of Epizyme's tazemetostat combined with R² regimen (ie lenalidomide + rituximab) in the treatment of second-line follicular lymphoma.
According to the China Drug Clinical Trial Registration and Information Publicity Platform, this is a randomized, double-blind, parallel-group, international multi-center Phase 3 clinical trial to evaluate the effect of tazemetostat or placebo combined with R² regimen on relapsed/refractory follicular lymphoma safety and efficacy in subjects with cancer
.
The primary objective of the trial was to evaluate and compare investigator-assessed progression-free survival (PFS)
The efficacy of tazemetostat in the treatment of follicular lymphoma has been validated in clinical trials
.
In June 2020, the drug was approved by the FDA for the treatment of adult patients with relapsed/refractory follicular lymphoma who have received at least 2 prior systemic therapies, as well as relapsed/refractory follicular lymphoma for whom there are no satisfactory alternative treatment options tumor in adult patients
references:
[1] China Drug Clinical Trials Registration and Information Publicity Platform.
[3] Epizyme Announces US FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma.
