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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tazemetostat
Trade Name: Tazverik
Date Designated: 11/14/2017
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
Epizyme, Inc.
400 Technology Square
4th Floor
Cambridge, Massachusetts 02139
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: tazemetostat
Trade Name: Tazverik
Marketing Approval Date: 06/18/2020
Approved Labeled Indication: TAZVERIK (tazemetostat) is indicated for: the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options.
Exclusivity End Date: 06/18/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for the treatment of adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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