Zydelof® is 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. Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies. Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies.
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 this indication may be contingent upon verification of clinical benefit in confirmatory trials.
BOXED WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS AND INTESTINAL PERFORATION
Fatal and/or serious hepatotoxicity occurred in 14 percent of Zydelof-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelof as recommended.
Fatal, and/or serious and severe diarrhea or colitis occurred in 14 percent of Zydelof-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelof as recommended.
Fatal and serious pneumonitis can occur. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelof as recommended.
Fatal and serious intestinal perforation can occur in Zydelof-treated patients. Discontinue Zydelof for intestinal perforation.