CLL
Approved in relapsed CLL in combination with rituximab where rituximab alone is appropriate due to comorbidities

ZYDELIG®
Safety Profile

Safety and tolerability profile demonstrated
in a relapsed patient population

AEs Reported in >10% of Patients and at a Higher Rate With ZYDELIG + Rituximab
  ZYDELIG + R
(n=110)
Rituximab alone
(n=108)
 
  AE* Any
grade (%)
Grade
≥3 (%)
Any
grade (%)
Grade
≥3 (%)
 
  Pneumonia 30 21 19 13  
  Diarrhea 32 11 19 0  
  Rash 25 4 6 1  
  Pyrexia 40 3 19 1  
  Chills 25 2 16 0  
  Decreased appetite 16 2 11 2  
  Abdominal pain 18 1 16 2  
  Nausea 27 1 23 0  
  Vomiting 15 0 8 0  
  • Most frequent serious adverse reactions (SAR) in clinical studies in combination with rituximab were pneumonia (23%), diarrhea (10%), pyrexia (9%), sepsis (8%) and febrile neutropenia (5%); SAR were reported in 59% of patients, and 17% discontinued therapy due to adverse reactions
  • Median duration of exposure to ZYDELIG was 8 months

*AEs are listed in descending order based on grade ≥3 occurrence in the ZYDELIG arm.

Diarrhea, abdominal pain, pneumonia, and rash include multiple preferred terms.

AE=adverse event; R=rituximab.

Treatment-Emergent Lab
Abnormalities Reported in ≥30%
of Patients at ≥5% Higher
Rate With ZYDELIG + Rituximab
  ZYDELIG + R
(n=110)
Rituximab alone
(n=108)
 
  Lab abnormality Any
grade (%)
Grade
3-4 (%)
Any
grade (%)
Grade
3-4 (%)
 
  Neutropenia 65 42 56 31  
  ALT increased 39 9 12 1  
  Leukopenia 31 8 23 8  
  • Treatment-emergent laboratory abnormalities reported in ≥20% to <30% of patients treated with ZYDELIG + rituximab (any grade/grade 3/4) were lymphocytopenia (21%/10%) and AST increased (28%/5%)

ALT=alanine aminotransferase; AST=aspartate aminotransferase.