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Find Clinical Drug Pipeline Developments & Deals by Epizyme
Ipsen acquires Epizyme’s lead medicine, Tazverik® (tazemetostat), a first-inclass, chemotherapy-free EZH2a inhibitor, which was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) in 2020.
The primary focus of the acquisition is on the lead medicine, Tazverik® (tazemetostat), a first-in-class, chemotherapy-free EZH2[1] inhibitor, which was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) in 2020.
Treatment with Tazverik (tazemetostat) and R2 was generally well tolerated and the adverse events were consistent with those contained in the prescribing information for both tazemetostat and R2, respectively.
TAZVERIK (tazemetostat), is a methyltransferase inhibitor of EZH21 is approved by the FDA for the treatment of certain patients with ES and certain patients with FL.
TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models.
First patient dosed in the randomized portion of symphony-1 (EZH-302), epizyme’s phase 1B/3 confirmatory study of Tazverik (tazemetostat) in combination with rituximab + lenalidomide (R2) for the treatment of follicular lymphoma.
Epizyme anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan.
Among the 13 patients evaluated in this standard dose escalation design, no Dose Limiting Toxicities (DLTs) were observed during the first cycle of treatment up to the highest dose of 800mg of TAZVERIK twice daily.
The expanded loan facility is a part of the original loan agreement where Epizyme drew down $70 million to fund the regulatory milestones owed to Eisai for the New Drug Application submissions and U.S. FDA approvals of TAZVERIK® for epithelioid sarcoma and follicular lymphoma.
Data supported the accelerated approval of TAZVERIK by the U.S. FDA for the treatment of epithelioid sarcoma in January 2020, and the accelerated approval of TAZVERIK by the FDA for the treatment of relapsed/refractory follicular lymphoma in June 2020.
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