INCLUDES HEAD-TO-HEAD DATA vs rituximab + Clb
In combination with chlorambucil (Clb) in first-line CLL1
START WITH GAZYVA
CLL-11 Trial Design1,2: CLL-11 was a Phase III, open-label, multicenter, 3-arm, randomized, parallel-group comparative study in patients with previously untreated
CD20-positive CLL and coexisting medical conditions or reduced renal function. Patients with creatinine clearance <30 mL/min or inadequate liver function were excluded.
Patients were treated with chlorambucil control (Arm 1), GAZYVA in combination with chlorambucil (Arm 2), or rituximab in combination with chlorambucil (Arm 3).
The safety and efficacy of GAZYVA was evaluated in a Stage I comparison of Arm 1 vs Arm 2 in 356 patients and a Stage II comparison of Arm 2 vs Arm 3 in 663 patients.
The primary endpoint was progression-free survival, as evaluated by an independent review committee. Secondary endpoints included overall response rate, complete
response rate, response duration, and minimal residual disease negativity.
Indication
GAZYVA® (obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously
untreated chronic lymphocytic leukemia (CLL).
Boxed WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
• Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death,
can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for
HBV infection before treatment initiation. Monitor HBV positive patients during and after treatment with
GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
• Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA
Please see the following pages for additional Important Safety Information
and brief summary of full Prescribing Information, including Boxed WARNINGS.