What is the generic name?

UMBRALISIB

What is the Trade Name for UMBRALISIB?

UKONIQ

What are the Indications for UMBRALISIB?

• 1 INDICATIONS AND USAGE UKONIQ is a kinase inhibitor indicated for the treatment of adult patients with: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen ( 1.1 ). Relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy ( 1.2 ). These indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.1 Marginal Zone Lymphoma UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14.1 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Follicular Lymphoma UKONIQ is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

References: https://open.fda.gov/