Epizyme nabs new FDA approval for Tazverik

19 June 2020

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in two follicular lymphoma (FL) indications, submitted by Epizyme (Nasdaq: EPZM), whose shares rose 5% yesterday, but were down nearly 11% at $18.26 by late morning today.

One is for adults with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.

The other is for patients with relapsed or refractory FL who have no satisfactory alternative treatment options.

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