Included In This Lesson
Outline
What is the generic name?
BELINOSTAT
What is the Trade Name for BELINOSTAT?
Beleodaq
What are the Indications for BELINOSTAT?
- 1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. (1)
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References: https://open.fda.gov/