- The FDA designates Epizyme's (EPZM -1.7%) lead product candidate tazemetostat for Fast Track review for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with an EZH2-activating mutation.
- In addition, the company announces that it has expanded the epithelial sarcoma cohort to 60 subjects (from 30) in its ongoing Phase 2 study in patients with genetically defined solid tumors after observing encouraging activity.
- On the negative front, development in synovial sarcoma has been terminated due to the lack of sufficient effect.
- Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers. It is being developed for the treatment of non-Hodgkin lymphoma, certain genetically defined solid tumors and (until now) synovial sarcoma.