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

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