Ipsen SA said on Monday it has withdrawn its oncology medicine Tazverik, known generically as tazemetostat, from all markets after an independent monitoring panel reviewing the Phase Ib/III SYMPHONY-1 trial reported safety concerns. The company’s announcement came after the trial committee determined that adverse events involving secondary blood cancers indicated the treatment’s risks may outweigh its benefits, prompting an immediate product pull.
The withdrawal covers both of tazemetostat’s approved uses - relapsed or refractory follicular lymphoma and epithelioid sarcoma - and is effective immediately. On the stock market the news corresponded with a roughly 3% decline in Ipsen shares.
The Independent Data Monitoring Committee overseeing SYMPHONY-1, which was evaluating tazemetostat in combination with lenalidomide and rituximab, concluded that emerging instances of secondary hematologic malignancies altered the drug’s safety profile compared with prior clinical evaluations. In a statement reflecting the company position, Christelle Huguet, Ipsen’s head of R&D, said:
"Emerging data from this confirmatory study have highlighted a safety profile that is unfavorable compared to that previously observed in clinical evaluation."
Tazverik received accelerated approval from the U.S. Food and Drug Administration in 2020 for both indications, with continued approval contingent on confirmatory trial results - the very data SYMPHONY-1 was intended to provide. Ipsen said it is engaging with the FDA on the formal steps required to withdraw the medicine.
As part of the company’s actions, tazemetostat treatment will be halted for all participants currently receiving it in SYMPHONY-1, a study that spans 229 sites across 15 countries. Those patients will continue to receive the other trial drugs, lenalidomide and rituximab, while the trial remains open for long-term safety follow-up but will not enroll any new participants. Ipsen also announced the discontinuation of all other active tazemetostat clinical trials and expanded access programs.
Despite the immediate clinical and regulatory fallout, Ipsen stated that the withdrawal of tazemetostat would not affect its financial guidance. The company said it will coordinate next steps with regulators as required.
Sectors affected: pharmaceutical companies, biotech investors, broader healthcare and capital markets that follow oncology drug approvals.