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Epizyme Reports the US FDA Acceptance of NDA for Tazverik (tazemetostat) to Treat Follicular Lymphoma

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Epizyme Reports the US FDA Acceptance of NDA for Tazverik (tazemetostat) to Treat Follicular Lymphoma

Shots:

  • The US FDA has accepted NDA for the accelerated approval of Tazverik for patients with relapsed/refractory FL prior treated with 2L+ systemic therapies
  • The US FDA has granted PR and designated its NDA as sNDA. The sNDA is based on P-II study that demonstrated clinical benefits and was well tolerated in FL patients with EZH2 activating mutations & with wild type EZH2
  • Tazverik is a methyltransferase inhibitor indicated to treat patients aged ≥16yrs. with metastatic or LA epithelioid sarcoma not eligible for complete resection with its anticipated PDUFA date as Jun 18- 2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Epizyme


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