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Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
PREGNANCY: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective non-hormonal contraception. Advise women not to breastfeed during treatment with tazemetostat and for one week after the final dose.
Tazemetostat increases the risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.
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