What is the generic name?

DUVELISIB

What is the Trade Name for DUVELISIB?

Copiktra

What are the Indications for DUVELISIB?

• 1 INDICATIONS AND USAGE COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. ( 1.1 ). Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. ( 1.2 ). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 1.1 Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies. 1.2 Follicular Lymphoma (FL) COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies. This indication is approved under accelerated approval based on overall response rate (ORR) [see Clinical Studies ( 14.2 )]; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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