About TAZVERIK® (tazemetostat)
TAZVERIK® is a methyltransferase inhibitor indicated in the United States for the treatment of:
● | Adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection. |
● | Adult patients with R/R 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. |
● | Adult patients with R/R FL who have no satisfactory alternative treatment options. |
These indications are approved under accelerated approval by the U.S. FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The most common (≥20%) adverse reactions in patients with ES are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with FL are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.
View the U.S. Full Prescribing Information here:
https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/sites/9/2022/11/03075215/TAZ-US-000213_TAZVERIK-US-PI-1.pdf
TAZVERIK® is approved in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable).
TAZVERIK® is a registered trademark of Epizyme Inc., an Ipsen company.
About Tazemetostat Clinical Development in China
HUTCHMED and Ipsen are developing tazemetostat in various hematological and solid tumors in Greater China. We are participating in Ipsen’s SYMPHONY-1 (EZH-302) study, leading it in China. We also initiated a Phase ІІ study in combination with our phosphoinositide 3-kinase delta (PІ3Kδ) inhibitor amdizalisib in patients with R/R FL in February 2023. We are generally responsible for funding all clinical trials of tazemetostat in China, including the portion of global trials conducted there.
SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab + lenalidomide (R2) in patients with R/R FL after at least one prior line of therapy (clinicaltrials.gov identifier: NCT04224493).
China combination study in R/R FL is an open-label, Phase ІІ study in approximately 140 patients to evaluate the safety, tolerability and preliminary anti-tumor efficacy of tazemetostat in combination with amdizalisib in patients with R/R lymphoma. The first patient was dosed in February 2023 (clinicaltrials.gov identifier: NCT05713110).
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.