FDA OKs Epizyme's tazemetostat for treatment-resistant follicular lymphoma

Under accelerated review status, the FDA approves Epizyme's (EPZM +4.5%) Tazverik (tazemetostat) for the treatment of adult patients with relapsed/refractory follicular lymphoma (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 and adults with relapsed/refractory FL who have no realistic treatment options.

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Accelerated approval stipulates certain post-marketing requirements including a confirmatory study to validate the treatment benefits.

The FDA approved the methyltransferase inhibitor in January for epithelioid sarcoma.

Jun. 18, 2020

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