Drugs

Ipsen Pulls Tazverik Due to Secondary Blood Cancer Risk

FDA says Ipsen will voluntarily withdraw its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious secondary blood cancers in patients receiving the therapy. In a safety alert, the agency said treatment with Tazverik was associated with higher rates of hematologic second primary malignancies (SPMs), including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), leading regulators to conclude that the drug’s risks now outweigh its benefits.

Tazverik, an EZH2 inhibitor, received accelerated approval in 2020 for adults and adolescents age 16 and older with metastatic or locally advanced epithelioid sarcoma who were not eligible for complete surgical resection. Later that year, the agency expanded the drug’s use to certain adults with relapsed or refractory follicular lymphoma.

At the time of approval, secondary malignancies were already identified as a potential safety concern, with an incidence rate of about 1.7%, FDA says. However, updated findings from the ongoing SYMPHONY-1 study showed substantially higher rates of new blood cancers among treated patients.

According to FDA, 18 of 318 patients (5.7%) receiving Tazverik in the trial developed hematologic SPMs as of March 6, 2026, while no such cases were reported in the control arm. Most cases involved MDS or AML, though investigators also reported B-cell acute lymphoblastic leukemia and clonal cytopenia of undetermined significance.

The agency says the disorders appeared to be severe and potentially irreversible. Three of the 18 affected patients died, and 14 others had not experienced resolution of the secondary malignancy.

Patients in the trial generally developed the new cancers after one to three years of treatment, though some cases emerged as early as 7.5 months after therapy initiation. FDA notes that several cases occurred after patients had discontinued Tazverik treatment.

The findings prompted the study’s independent data monitoring committee to recommend halting enrollment in the SYMPHONY-1 trial and immediately discontinuing Tazverik therapy for all study participants. Ipsen subsequently informed FDA that it would stop treatment in the study, terminate expanded access programs, and voluntarily remove the drug from the U.S. market.

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