FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer | FDA

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer | FDA



FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

The U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ). Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults.

The most common side effects for patients taking Tazverik were pain, fatigue, nausea, decreased appetite, vomiting and constipation. Patients treated with Tazverik are at increased risk of developing secondary malignancies including: T-cell lymphoblastic lymphoma (a type of blood cancer that affects the lymphatic system usually found in the lymph nodes), myelodysplastic syndrome (a disorder resulting from poorly formed or dysfunctional blood cells) and acute myeloid leukemia (a cancer of the blood and bone marrow). The FDA advises health care professionals to tell females of reproductive potential to use effective contraception during treatment with Tazverik and for six months after the final dose. Males with a female partner of reproductive potential should use effective contraception during treatment with Tazverik and for three months after the final dose. Females who are pregnant or breastfeeding should not take Tazverik because it may cause harm to a developing fetus or newborn baby. Tazverik must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.