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Epizyme Announces FDA Committee Review of Tazemetostat NDA

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Epizyme, Inc. announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA is scheduled to review data supporting the New Drug Application (NDA), seeking accelerated approval of the lead candidate, tazemetostat, on Dec 18.

The proposed indication for tazemetostat, to be discussed at this upcoming ODAC meeting, is metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

In July, the FDA accepted for filing the NDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery with Priority Review and a Prescription Drug User-Fee Act (PDUFA) action date of Jan 23, 2020. The NDA was based primarily on data from the 62-patient epithelioid sarcoma cohort of its ongoing phase II study on tazemetostat.

We note that Epizyme is developing tazemetostat, an oral, first-in-class EZH2 inhibitor, in a broad clinical development program through company-sponsored studies and collaborations. This program is evaluating the drug as both a monotherapy and a combination treatment in hematological malignancies and solid tumors for late and early lines of treatment.

Although the FDA will consider the recommendation of the panel, it is not bound by it.

A potential approval of the candidate will be a significant boost for this late-stage biopharmaceutical company, which has limited candidates in its pipeline.

Shares of the company have skyrocketed 155.8% year to date compared with the industry’s growth of 4.6%.


Meanwhile, the company is also exploring additional molecules in its novel G9a inhibitor program. Since Epizyme has limited sources for drug development, it inked collaborations with bigwigs like GlaxoSmithKline (GSK - Free Report) and Roche (RHHBY - Free Report) , among others.

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