FDA panel unanimously backs approval of Epizyme's tazemetostat for epithelioid sarcoma

Shares in Epizyme gained as much as 16% Wednesday after an FDA advisory committee voted 11 to 0 that the benefits of tazemetostat in patients with metastatic or locally advanced epithelioid sarcoma ineligible for curative surgery outweigh the drug's risks. CEO Robert Bazemore suggested that if Epizyme's marketing application is approved, the experimental EZH2 inhibitor, also known as EPZ-6438, could "change how patients with this devastating cancer are treated." He added that the company's "commercial-readiness is complete, and we look forward to finalising our dialogue with the FDA."

The US filing is based primarily on data from the 62-patient epithelioid sarcoma cohort of Epizyme's ongoing Phase II trial of tazemetostat. Findings reported earlier this year at the American Society of Clinical Oncology (ASCO) annual meeting showed that treatment with tazemetostat led to a 15% objective response rate and a 26% disease control rate, while the drug was generally well-tolerated with a favourable safety profile. The FDA is expected to make a decision by January 23 of next year.

Last month, Epizyme said it reached agreements for up to $270 million in funding to go toward anticipated launches next year of tazemetostat for epithelioid sarcoma and follicular lymphoma. The agreements include $100 million upfront from Royalty Pharma, with up to $100 million more in future equity. Further, existing royalty rates owed by Epizyme to Royalty Pharma on worldwide sales of tazemetostat outside Japan were reduced, following the latter's recent acquisition of certain royalty rights from Eisai. 

For related analysis, see ViewPoints: Epizyme hopes first time's a charm for NDA submission. See also ViewPoints: Epizyme turns Royalty Pharma's appetite for risk into room to roam.  

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