"first-in-class" anti-cancer therapy qualified for priority review is expected to be approved early next year

Epithelial sarcoma is a very rare malignant tumor of soft tissue, mainly in young people aged 20-40 years old, with a total survival period of about 30 monthsMore than 90% of epidermal sarcoma is characterized by in1 protein expression deficiencyINI1 (also known as hSNF5) is part of the evolutionaryly conservative "chromatin reconstruction complex" SWI/SNF familyThis compound plays an important role in suppressing the activation of cancer genesMutations and deletions of INI1 can lead to abnormal histone methylation, induce malignant transformation of cells, and cell proliferation depends on the activity of EZH2, as histone methyl metastases, mutated or overexpressed EZH1/2, inhibits the transcriptional activity of cancer-suppressing genesBy inhibiting EZH2, tazemetostat was able to inhibit the methylation of histone H3 lysine 27 (H3K27) and restore the expression of cancer-suppressing genesTazemetostat's research and development strategy (Photo: Epizyme)
Epizyme's research and development strategy for tazemetostat includes three directions: one is a single-drug therapy for diseases that directly rely on EZH2 activity, including INI1-negative solid tumors, mesothelioma, non-Hodgkin's lymphoma (NHL), etc.; The second is as a combination of chemotherapy treatment, combined with the chemotherapy drug R-CHOP, the treatment of diffuse large B-cell lymphoma (DLBCL), etc., and the third is combined with the immunocheckpoint inhibitor Tecentriq to treat non-small cell lung cancer (NSCLC)The results of a Phase 2 trial of Tazemetostat for the treatment of epithelial sarcoma (Photo: Epizyme.com)the FDA's decision is based on positive results from tazemetostat's treatment of patients with epithelioma colostrum in Phase 2 clinical trialsThe results showed that the objective remission rate of tazemetostat was 15% and the disease control rate was 26%The median OS has not yet arrivedIn addition, tazemetostat demonstrates good safety and toleranceRobert Bazemore, President and CEO ofEpizyme, said, "I am delighted that the FDA has accepted and qualified for the preferential review of the NDA at tazemetostatThis means that Epizyme is another important step towards rewriting the goal of cancer and other treatments for serious diseasesWe look forward to working closely with the FDA to bring this potential 'first-in-class' EZH2 inhibitor to doctors and patients as an important new treatment option"
References:s1 sEpizyme Reports Updated Data From Phase 2 Trial of Tazemetostat for Epithelioid Sarcoma at 2019 ASCO MeetingRetrieved July 25, 2019, from https://epizyme.gcs-web.com/news-releases/news-release-details/epizyme-reports-updated-data-phase-2-trial-tazemetostatHoyd July 25, 2019, from https://epizyme.gcs-web.com/news-releases/news-release-details/epizyme-announces-fda-filing-acceptance-new-drug-application-and, Tazemetostat, an EZH2, in relapsed or d'etre, b-cell non-Hodgkin lymphoma and advanced solid post: a first-in-human, open-label, phase 1Retrieved July 25, 2019, from https:// (18) 30145-1/fulltext
original title: Courier"first-in-class" cancer treatment is eligible for priority review and is expected to be accelerated early next year