Ipsen (IPSEY) announced it is voluntarily withdrawing Tazverik (tazemetostat) from all markets and indications, including follicular lymphoma (FL) and epithelioid sarcoma (ES).
The decision follows emerging safety data from the ongoing Phase Ib/III SYMPHONY-1 trial, which evaluated Tazemetostat in combination with lenalidomide plus rituximab (R2) vs R2 in follicular lymphoma.
The Independent Data Monitoring Committee (IDMC) advised that, due to adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen.
As a result, Ipsen has stopped treatment with Tazemetostat for all patients enrolled in SYMPHONY-1 trial. Participants will continue on standard of care therapy with Lenalidomide plus Rituximab, while the study remains open for long-term safety follow-up. Ipsen is also discontinuing all active Tazemetostat clinical trials and expanded access programs.
"Tazverik's withdrawal is extremely disappointing, but patient safety remains our priority," said Christelle Huguet PhD & EVP Head of R&D at Ipsen. She noted that the confirmatory study highlighted a safety profile less favorable than previously observed. Ipsen will work closely with investigators and regulators to support patients through transition plans.
Tazverik had received U.S. FDA accelerated approval in 2020 for adults with relapsed or refractory FL (EZH2 mutant or with no satisfactory alternatives) and for adolescents and adults aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection. Continued approval was contingent on confirmatory trial results, which SYMPHONY-1 was designed to provide.
Ipsen stated that the withdrawal is not expected to impact the Company's financial guidance.
Ipsen has traded between EUR 90.20 and EUR 165.10 over the past year. The stock is currently trading at EUR 155.90, down 5.57%.
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