Romidepsin
Product manufactured by Teva Parenteral Medicines, Inc.
Indications and Purposes
| 1 Indications And Usage Romidepsin Is A Histone Deacetylase (hdac) Inhibitor Indicated For: Treatment Of Cutaneous T-Cell Lymphoma (ctcl) In Adult Patients Who Have Received At Least One Prior Systemic Therapy ( 1.1 ). Treatment Of Peripheral T-Cell Lymphoma (ptcl) In Adult Patients Who Have Received At Least One Prior Therapy ( 1.2 ). This Indication Is Approved Under Accelerated Approval Based On Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials ( 14.2 ). 1.1 Cutaneous T-Cell Lymphoma Romidepsin Is Indicated For The Treatment Of Cutaneous T-Cell Lymphoma (ctcl) In Adult Patients Who Have Received At Least One Prior Systemic Therapy. 1.2 Peripheral T-Cell Lymphoma Romidepsin Is Indicated For The Treatment Of Peripheral T-Cell Lymphoma (ptcl) In Adult Patients Who Have Received At Least One Prior Therapy. This Indication Is Approved Under Accelerated Approval Based On Response Rate [see Clinical Studies (14.2) ]. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. |
All Formulated Excipients (0 Total)
None
Active Ingredients ( 1 Total)
| Name | Structure | ZINC ID(s) |
|---|---|---|
| 1. Romidepsin |
|
ZINC100371951 |