FDA grants accelerated approval for Tazverik to treat epithelioid sarcoma

The US Food and Drug Administration on Thursday granted accelerated approval to Tazverik (tazemetostat) 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 (surgically removing all of a tissue, structure, or organ).

The drug was developed by US biotech Epizyme (Nasdaq: EPZM), whose shares closed up 4.74% at $26.72 yesterday, but that was likely influenced by Citigroup tipping the cancer drug developer as a potential takeover candidate.

Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. The company’s ongoing, global, randomized, controlled confirmatory trial assessing the combination of Tazverik plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES is underway.