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The sarcoma and follicular lymphoma drug tazemetostat (Tazverik) is being voluntarily pulled from the US and all other markets due to the risk of secondary hematologic malignancies, according to drugmaker Ipsen.
The FDA granted tazemetostat accelerated approval in 2020 for patients with locally advanced/metastatic epithelioid sarcoma and for those with relapsed/refractory (r/r) follicular lymphoma whose tumors have an EZH2 mutation. The blood cancer risk was discovered in SYMPHONY-1, the confirmatory trial for the follicular lymphoma approval, but Ipsen is pulling the drug for both indications.
In a press release, the company said it’s discontinuing tazemetostat trials and expanded access programs and working with the FDA to execute the withdrawal.
SYMPHONY evaluated tazemetostat, an EZH2 inhibitor, in combination with lenalidomide plus rituximab (R2) vs R2 alone. An independent data monitoring committee advised the company that the drug’s risks may outweigh its benefits after the secondary hematologic malignancy risk emerged.
Investigators will continue to monitor participants for long-term safety, but tazemetostat patients will be switched to the R2 alone arm, and no new patients will be enrolled.
Tazemetostat sales had been declining even before the withdrawal, dropping by 14% in North America from fiscal year 2024 to 2025. The company blamed “limited demand growth and adverse pricing” in a financial report.
No other drugs are FDA-approved specifically for epithelioid sarcoma, but other options for r/r follicular lymphoma include the bispecific T‑cell engagers epcoritamab (Epkinly, Genmab/AbbVie), which is approved in combination with R2 for r/r follicular lymphoma, among other indications.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
