• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Tazverik (tazemetostat)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Tazverik (tazemetostat)

  • Profile

Profile

Contact Information

Contact: Epizyme
Website: https://www.tazverik.com/

Currently Enrolling Trials

    Show More

    Tazverik (tazemetostat) - 2 indications

    Scroll down for more information on each indication:

    • for patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection; approved January 2020
    • for adults with EZH2 mutation positive relapsed or refractory (R/R) follicular lymphoma (FL) and R/R FL with no satisfactory alternative treatment options; approved June of 2020

    General Information

    Tazverik (tazemetostat) blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing.

    Tazverik is specifically indicated for the following:

    • adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection
    • adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies
    • adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options

    Tazverik is supplied as a tablet for oral administration. The recommended dose is 800 mg orally twice daily with or without food until disease progression or unacceptable toxicity. Swallow tablets whole. Do not take an additional dose if a dose is missed or vomiting occurs after Tazverik, but continue with the next scheduled dose.

    Mechanism of Action

    Tazverik (tazemetostat) is a potent, selective, and orally bioavailable small-molecule inhibitor of EZH2 enzymatic activity. EPZ-6438 induces apoptosis and differentiation specifically in SMARCB1-deleted MRT cells.

    Side Effects

    Adverse effects associated with the use of Tazverik in patients with epithelioid sarcoma may include, but are not limited to, the following:

    • pain
    • fatigue
    • nausea
    • decreased appetite
    • vomiting
    • constipation

    Adverse effects associated with the use of Tazverik in patients with follicular lymphoma may include, but are not limited to, the following:

    • fatigue
    • upper respiratory tract infection
    • musculoskeletal pain
    • nausea
    • abdominal pain

    Indication 1 - for patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection

    approved January 2020

    Clinical Trial Results

    The FDA approval of Tazverik for epithelioid sarcoma was based on the results of a clinical trial enrolling 62 patients with metastatic or locally advanced epithelioid sarcoma. During the clinical trial, patients received 800 milligrams (mg) of Tazverik twice a day until the disease progressed or the patient reached an unacceptable level of toxicity. Tumor response assessments were performed every eight weeks during the clinical trial. The trial measured how many patients experienced complete or partial shrinkage (by a certain amount) of their tumors during treatment (overall response rate). The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response. Of the nine patients that had a response, six (67%) patients had a response lasting six months or longer.

    Indication 2 - for adults with EZH2 mutation positive relapsed or refractory (R/R) follicular lymphoma (FL) and R/R FL with no satisfactory alternative treatment options

    approved June of 2020

    Clinical Trial Results

    The FDA approval of Tazverik for follicular lymphoma was based on an open-label, single-arm, multi-center Phase 2 clinical trial in patients with histologically confirmed FL whose disease had progressed following at least two prior systemic treatment regimens. Patients were enrolled into two cohorts: one cohort enrolled 45 patients with EZH2 activating mutations and a second cohort enrolled 54 patients with wild-type EZH2. All patients were treated with 800 mg of tazemetostat, administered orally twice a day. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR). Among the 45 FL patients with an EZH2 activating mutation who received Tazverik and treated with at least 2 prior systemic therapies, the ORR was 69%, with 12% of patients achieving a complete response and 57% achieving a partial response. The median DOR was 10.9 months and ongoing. Among the 54 FL patients with wild-type EZH2 who received Tazverik and treated with at least 2 prior systemic therapies, the ORR was 34%, with 4% of patients achieving a complete response and 30% achieving a partial response. The median DOR was 13.0 months.

    Approval Date: 2020-01-01
    Company Name: Epizyme
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing