|
1 Indications And Usage Zydelig Is A Kinase Inhibitor Indicated For The Treatment Of Patients With: Relapsed Chronic Lymphocytic Leukemia (Cll), In Combination With Rituximab, In Patients For Whom Rituximab Alone Would Be Considered Appropriate Therapy Due To Other Co-Morbidities. ( 1.1 ) Relapsed Follicular B-Cell Non-Hodgkin Lymphoma (Fl) In Patients Who Have Received At Least Two Prior Systemic Therapies. ( 1.2 ) Relapsed Small Lymphocytic Lymphoma (Sll) In Patients Who Have Received At Least Two Prior Systemic Therapies. ( 1.3 ) Limitation Of Use: Zydelig Is Not Indicated And Is Not Recommended For First-Line Treatment Of Any Patient. ( 1.1 , 1.2 , 1.3 ) Zydelig Is Not Indicated And Is Not Recommended In Combination With Bendamustine And/or Rituximab For The Treatment Of Fl. ( 1.2 ) Accelerated Approval Was Granted For Fl And Sll Based On Overall Response Rate. Improvement In Patient Survival Or Disease Related Symptoms Has Not Been Established. Continued Approval For These Indications May Be Contingent Upon Verification Of Clinical Benefit In Confirmatory Trials. 1.1 Relapsed Chronic Lymphocytic Leukemia Zydelig Is Indicated, In Combination With Rituximab, For The Treatment Of Patients With Relapsed Chronic Lymphocytic Leukemia (Cll) For Whom Rituximab Alone Would Be Considered Appropriate Therapy Due To Other Co-Morbidities. Limitation Of Use Zydelig Is Not Indicated And Is Not Recommended For First Line Treatment Of Patients With Cll. 1.2 Relapsed Follicular B-Cell Non-Hodgkin Lymphoma Zydelig Is Indicated For The Treatment Of Patients With Relapsed Follicular B-Cell Non-Hodgkin Lymphoma (Fl) Who Have Received At Least Two Prior Systemic Therapies. Accelerated Approval Was Granted For This Indication Based On Overall Response Rate [See Clinical Studies (14.2) ]. An Improvement In Patient Survival Or Disease Related Symptoms Has Not Been Established. Continued Approval For This Indication May Be Contingent Upon Verification Of Clinical Benefit In Confirmatory Trials. Limitation Of Use Zydelig Is Not Indicated And Is Not Recommended For First Line Treatment Of Patients With Fl. Zydelig Is Not Indicated And Is Not Recommended In Combination With Bendamustine And/or Rituximab For The Treatment Of Fl. 1.3 Relapsed Small Lymphocytic Lymphoma Zydelig Is Indicated For The Treatment Of Patients With Relapsed Small Lymphocytic Lymphoma (Sll) Who Have Received At Least Two Prior Systemic Therapies. Accelerated Approval Was Granted For This Indication Based On Overall Response Rate [See Clinical Studies (14.3) ]. An Improvement In Patient Survival Or Disease Related Symptoms Has Not Been Established. Continued Approval For This Indication May Be Contingent Upon Verification Of Clinical Benefit In Confirmatory Trials. Limitation Of Use Zydelig Is Not Indicated And Is Not Recommended For First Line Treatment Of Patients With Sll.
|