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FDA Actions & Updates

The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.

Monday, January 27, 2020

FDA Approves Tazemetostat for Advanced Epithelioid Sarcoma

The FDA granted accelerated approval to tazemetostat for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

Efficacy was investigated in a single-arm cohort (Cohort 5) of a multi-center trial (Study EZH-202, NCT02601950) in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients were required to have INI1 loss, detected using local tests, and an Eastern Cooperative Oncology Group performance status of 0-2. Patients received tazemetostat 800 mg orally twice daily until disease progression or unacceptable toxicity. The major efficacy outcome measures were confirmed overall response rate (ORR) according to RECIST v1.1 (assessed by blinded independent central review) and duration of response.

The ORR for the 62 patients in Cohort 5 was 15 percent (95% CI: 7%, 26%), with 1.6 percent having complete responses and 13 percent partial responses; 67 percent of those responding had responses lasting 6 months or longer.

The most common adverse reactions (incidence ≥20%) were pain, fatigue. nausea, decreased appetite, vomiting and constipation.

The recommended tazemetostat dose is 800 mg taken orally twice daily with or without food.