Epizyme Inc.’s (EPZM) first drug TAZVERIK, which was granted accelerated FDA approval for the treatment of metastatic or locally advanced epithelioid sarcoma last month, will face the U.S regulatory agency again in June.
The Company has sought accelerated approval of TAZVERIK for patients with relapsed or refractory follicular lymphoma who have received at least two prior lines of systemic therapy. The FDA decision date is set for June 18, 2020.
While analysts expect Tazemetostat to bring in peak sales of only $100 million in the epithelioid sarcoma indication, the picture is different for the follicular lymphoma market. If approved for follicular lymphoma, Tazemetostat could achieve more than $500 million in peak sales.
Commenting on the developments, Robert Bazemore, chief executive officer of Epizyme, said, “The June 2020 PDUFA date positions TAZVERIK for two FDA approvals within six months of each other, which would be a remarkable achievement for Epizyme.
EPZM has traded in a range of $9.74 to $27.82 in the last 1 year. The stock is up 3.96% at $23.11 in pre-market trading on Friday.
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