Tazverik accelerated approvals withdrawn for epithelioid sarcoma and follicular lymphoma
- Sponsor
- Ipsen
- Drug
- Tazverik · tazemetostat
- Indication
- epithelioid sarcoma; relapsed/refractory follicular lymphoma
Ipsen voluntarily withdrew Tazverik's three FDA accelerated-approval indications after SYMPHONY-1 trial showed an increased rate of second primary malignancies. Effective via Federal Register 2026-06-22.
What this means
Tazverik is a cancer pill that targets a protein called EZH2, used since 2020 for a rare sarcoma and for a type of slow-growing lymphoma when other options had run out. Ipsen withdrew it after a confirmatory trial showed patients on the combination treatment developed more secondary blood cancers than expected, suggesting the risks could outweigh the benefits. Patients currently taking Tazverik should consult their oncologist about transitioning to another therapy.
From the source
FDA's "Withdrawn Cancer Accelerated Approvals" listing was updated 2026-06-22 to add two Tazverik (tazemetostat) entries — the only new withdrawals on this update cycle. The Federal Register notice (Epizyme, Inc.; Withdrawal of Approval of NDA, document 2026-12367) made the action formally effective the same day.
Two rows added:
Tazverik (tazemetostat) — Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Approved 1/23/2020. Withdrawn 6/22/2026.
Tazverik (tazemetostat) — Treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation and who have received at least 2 prior systemic therapies, AND treatment of adult patients with R/R FL who have no satisfactory alternative treatment options. Approved 6/18/2020. Withdrawn 6/22/2026.
Withdrawal is voluntary on Ipsen's part. Per the company's 2026-03-09 announcement, the decision followed a notification (initially flagged by Epizyme on 2026-03-06) of an increased rate of second primary malignancies in the Tazverik arm of the Phase 3 SYMPHONY-1 study (EZH-302) — the confirmatory trial required by the accelerated-approval pathway. An independent data monitoring committee concluded that secondary hematologic malignancies in the combination arm meant potential risks could outweigh benefits.
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work
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