Epizyme’s Tazverik Gets Accelerated Approval

FDA has granted accelerated approval for Epizyme’s Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Approval was based on data from 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, an agency release says. “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,” it says.

The ORR for the 62 patients in the cohort was 15% with 1.6% having complete responses and 13% partial responses; 67% of those responding had responses lasting six months or longer, FDA says. The most common adverse reactions (incidence ≥20%) were pain, fatigue. nausea, decreased appetite, vomiting and constipation.

View full prescribing information for Tazverik.