During the first 2 treatment cycles with BLINCYTO ®1
100
80
60
40
41.6%
of evaluable patients achieved
CR/CRh* (n=77/185; 95% CI: 34.4-49.1)1
Median of 2 treatment cycles
• Range of 1 to 5 treatment cycles
9.2% CRh* (95% CI: 5.4-14.3)1
• Up to 2 cycles of induction
20
0
81% of these responses occurred within Cycle 1 (n=62/77) 1
19% of these responses occurred within Cycle 2 (n=15/77) 1
• Up to 3 cycles of consolidation
32.4% CR (95% CI: 25.7-39.7)1
BLINCYTO® (N=185)1
MRD Response
75.3%
Allogeneic Transplant
with CR/CRh* also had an MRD response
(defined as MRD by PCR < 1 x 10 -4)
(n=58/77; 95% CI: 64.2-84.4) 1
39%
MRD=minimal residual disease
of patients who achieved
CR/CRh* went on to receive
allogeneic transplant
(n=30/77) 1
• Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment.
The majority of these events were observed in the setting of CRS. The median time to onset was 15 days. Grade 3 or
greater elevations in liver enzymes occurred in 6% of patients outside the setting of CRS and resulted in treatment
discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to
the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise
to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
• Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI)
changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients
previously treated with cranial irradiation and anti-leukemic chemotherapy.
• Preparation an YZ[