Epizyme (EPZM -3.3%) slips on modestly higher volume after announcing that the FDA has accepted for review its marketing application seeking accelerated approval for tazemetostat for the treatment of epithelioid sarcoma. As is typical for a filing like this, the bulk of the supporting efficacy data were generated in a Phase 2 study.
The aim of accelerated approval is to enable more timely patient access to drugs that meet unmet medical needs. It is conditional since it is based on a smaller dataset than a customary application based on Phase 3 studies. In order to apply for full approval, drug makers have to conduct at least one late-stage (Phase 3) study to confirm safety and efficacy which is what Epizyme plans to do.
Investors appear concerned about an additional study, but it is to be expected and should not affect the accelerated review timeline or dampen commercial sales (assuming a positive outcome).
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