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Well-characterized safety profile in relapsed patients
Relapsed follicular lymphoma in patients who have received at least two prior systemic therapies
Relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities
Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies
Accelerated approval was granted for follicular lymphoma and SLL based on overall response rate. An 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.
ZYDELIG is not indicated or recommended for first-line treatment of any patient or in combination with bendamustine and/or rituximab for the treatment of follicular lymphoma.