X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
Details:
TAZVERIK® (tazemetostat) is a methyltransferase inhibitor indicated in the United States for the treatment of relapsed/refractory follicular lymphoma.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
Eisai will provide Tazverik free of charge to the National Cancer Center Hospital as the drug to be used in a clinical trial of Tazemetostat, a first-in-class, oral small molecule inhibitor of the epigenetic enzyme EZH2, for pediatric and AYA patients with malignant tumors.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Cancer Center
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 03, 2023
Details:
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.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ipsen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 12, 2022
Details:
TAZVERIK® (tazemetostat) 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 epithelioid sarcoma not eligible for complete resection.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
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.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ipsen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 27, 2022
Details:
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.
Lead Product(s): Tazemetostat,Rituximab,Lenalidomide
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
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.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Epizyme
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
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.
Lead Product(s): Tazemetostat,Lenalidomide,Rituximab
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
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.
Lead Product(s): Tazemetostat,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $85.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 27, 2022
Details:
The approval of “Tazverik” in Japan is based on data including results from Study 206, which is a multicenter, open-label, single-arm Phase II clinical study conducted in Japan by Eisai, and other clinical studies conducted by Epizyme, Inc. outside of Japan.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2021
Details:
Tazverik” is a first-in-class, oral small molecule inhibitor that targets EZH2. This approval is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206)1 in Japan conducted by Eisai and other studies2 conducted by Epizyme, Inc.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2021
Details:
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.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2021
Details:
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.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharmakon Advisors
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing November 06, 2020
Details:
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.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
The sNDA for TAZVERIK™ is approved for two distinct follicular lymphoma (FL) indications: Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation, Patients with relapsed/refractory FL who have no satisfactory alternative treatment options.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Tazverik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
Details:
Epizyme to report their pooled data from the two Phase 2 study cohorts of tazemetostat for epithelioid sarcoma, which supported the approval of TAZVERIK™ in January, as well as a presentation of the trial design for their ongoing confirmatory trial in epithelioid sarcoma.
Lead Product(s): Tazemetostat,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Approval would expand TAZVERIK™ label into second indication PDUFA target action date scheduled for June 18, 2020.
Lead Product(s): Tazemetostat
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2020
Details:
First and Only EZH2 Inhibitor Approved by U.S. Food and Drug Administration. In a Phase 2 Epithelioid Sarcoma Cohort Efficacy study, TAZVERIK's efficacy was evaluated.
Lead Product(s): Tazemetostat,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
