header mobile logo

EPITHELIOID SARCOMA IS AN AGGRESSIVE SUBTYPE OF SOFT TISSUE SARCOMA1

Epithelioid sarcoma has a high rate of local recurrence and has metastatic potential1

bag-iv

42-77% recurrence rate have been observed despite surgical excision and chemoradiotherapy3,4

lymph-nodes

Tendency to locally metastasize to regional lymph nodes1

lungs

Distant metastatic spread to other areas of the body1

Patients with metastatic epithelioid sarcoma have a poor prognosis1,2,5

Median overall survival is approximately 8 to 12 months.2,5

References: 1. Noujaim J, Thway K, Bajwa Z, et al. Epithelioid sarcoma: opportunities for biology‐driven targeted therapy. Frontiers in Oncology. 2015;5:1‐11. 2. Spillane AJ, Thomas JM, and Fisher C. Epithelioid sarcoma: The clinicopathological complexities of this rare soft tissue sarcoma. Ann Surg Oncol. 2000;7(3):218-225. 3. Evans HL and Baer SC. Epithelioid Sarcoma: A Clinicopathologic and Prognostic Study of 26 cases. Semin Diagn Pathol. 1993;10(4):286-91. 4. Chase DR and Enzinger FM. Epithelioid sarcoma. Diagnosis, prognostic indicators, and treatment. Am J Surg Pathol. 1985;9(4):241-63. 5. Jones RL, Constantinidou A, Olmos D, et al. Role of palliative chemotherapy in advanced epithelioid sarcoma. Am J Clin Oncol. 2012;35(4):351-357.

IMPORTANT SAFETY INFORMATION AND INDICATION

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 758 adults who received TAZVERIK 800 mg twice daily as monotherapy, myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or B-cell acute lymphoblastic leukemia (B-ALL) occurred in 1.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0‑45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information.