The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers about the voluntary withdrawal of Tazverik (tazemetostat) tablets from the market due to an increased rate of hematologic second primary malignancies (SPMs) — the development of new blood cancers in people treated with Tazverik for a different cancer. As a result, it was determined that the risks of treatment with Tazverik outweigh its benefits.

Tazverik was approved in 2020 to treat individuals aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (a rare cancer that starts as cell growth in the soft tissue) who are not eligible for complete resection. Later that year, it was approved to treat certain adults with relapsed or refractory follicular lymphoma, a slow-growing type of B-cell non-Hodgkin lymphoma. FDA approved both indications under accelerated approval. At the time of accelerated approval, SPMs were recognized as a risk with Tazverik, with an incidence rate of 1.7%. However, with the Symphony 1 trial (NCT NCT04224493), the rate was found to exceed 5% over a median treatment duration of 15.8 months (range: 6.9 to 33 months).

An increased incidence of hematologic SPMs among people taking Tazverik was observed in the study, “SYMPHONY-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination with Lenalidomide Plus Rituximab in Subjects with Relapsed/Refractory Follicular Lymphoma.” In this study, as of March 6, 2026, 18 out of 318 (5.7%) patients treated with Tazverik developed hematologic SPMs, compared to no reported events among patients in the control arm. Most SPMs were myelodysplastic syndrome (MDS) and acute myeloid leukemia; others included B-cell acute lymphoblastic leukemia and clonal cytopenia of undetermined significance. Treatment-emergent acute leukemias and MDS are serious and life-threatening disorders that are not expected to be reversible, as evidenced by 3 deaths in the 18 patients, and 14 patients without resolution of the hematologic SPM.

Most participants who developed the new blood cancers were receiving Tazverik for 1-3 years. The SPMs started as early as 7.5 months after beginning treatment and occurred in some patients after stopping treatment. Based on these findings, an independent data monitoring committee recommended that enrollment on the SYMPHONY-1 trial should be stopped and that all patients receiving Tazverik should discontinue treatment immediately. Shortly thereafter, the sponsor, Ipsen, notified FDA of their plans to discontinue Tazverik treatment for patients in the clinical study and withdraw Tazverik from the U.S. market. The study will remain open for long-term safety follow-up of participants. All expanded access programs for Tazverik will be discontinued as well.

FARXIGA is sodium-glucose cotransporter 2 (SGLT2) inhibitor that works by reducing the reabsorption of glucose and sodium in the kidneys.

Type 2 diabetes is a chronic condition that occurs when the body does not use insulin well and cannot keep blood sugar at normal levels. It develops over many years and is usually diagnosed in adults. According to the Centers for Disease Control and Prevention, more than 40 million Americans have diabetes, and 90% to 95% of those individuals have type 2 diabetes.

The prescribing information for the generic dapagliflozin tablets includes the same contraindications, warnings and precautions as FARXIGA. Dapagliflozin is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients. Dapagliflozin carries warnings such as diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis, and volume depletion. The most common side effects reported in the clinical trials for dapagliflozin were female genital mycotic infections, nasopharyngitis, and urinary tract infections.

Healthcare providers should review the full prescribing information for complete safety and dosing information.

The FDA granted approval of dapagliflozin tablets to multiple generic drug applicants. Please check the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) for a complete list of approvals and contact the manufacturers for information about a medicine’s availability.

FARXIGA is a registered trademark of the AstraZeneca group of companies.

For more information about generic drugs, visit https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs.