The FDA has alerted healthcare providers and patients about an increased risk of new blood cancers tied to Tazverik (tazemetostat) and said the drug’s sponsor plans to withdraw the product from the U.S. market.
Tazverik was approved under the FDA’s accelerated approval pathway in 2020 to treat patients 16 and older with metastatic or locally advanced epithelioid sarcoma and certain adults with relapsed or refractory follicular lymphoma. The agency said new data showed the risks of treatment outweigh the drug’s benefits.
According to a May 11 FDA safety alert, 18 out of 318 patients, or 5.7%, treated with Tazverik in the Phase 1b/3 Symphony-1 trial developed hematologic second primary malignancies, compared to no reported events in the control arm. The cancers included myelodysplastic syndrome, acute myeloid leukemia, B-cell acute lymphoblastic leukemia and clonal cytopenia of undetermined significance.
The FDA said the rate of second primary malignancies previously was recognized at 1.7% during the drug’s accelerated approval process, but it exceeded 5% in the newer study over a median treatment duration of 15.8 months.
The agency said treatment-emergent acute leukemias and myelodysplastic syndrome were serious and life-threatening, with three deaths reported among the 18 affected patients and 14 patients experiencing unresolved hematologic malignancies. Ipsen said it will discontinue Tazverik treatment in the study, end expanded access programs and withdraw the drug from the market.
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