1 INDICATIONS AND USAGE
1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
14 CLINICAL STUDIES
14.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Combination Therapy
A 17p deletion was detected in 24% of patients, TP53 mutations in 25%, 11q deletion in 32%, and unmutated IgVH in 63%.
Monotherapy
In the study, 17p deletion was confirmed in peripheral blood specimens from patients using Vysis CLL FISH Probe Kit, which is FDA approved for selection of patients for VENCLEXTA treatment.
21% had documented 17p deletion
39% had documented 17p deletion
14.2 Acute Myeloid Leukemia
Study M14-358
| Characteristic | VENCLEXTA in Combination with Azacitidine N = 67 | VENCLEXTA in Combination with Decitabine N = 13 |
|
Mutation analyses detecteda; % |
||
|
TP53 |
21 |
31 |
|
IDH1 or IDH2 |
27 |
0 |
|
FLT-3 |
16 |
23 |
|
NPM1 |
19 |
15 |
aIncludes 6 patients with insufficient sample for analysis in the azacitidine group and 4 in the decitabine group.
Study M14-387
| Characteristic | VENCLEXTA in Combination with Low-Dose Cytarabine N = 61 |
|
Mutation analyses detecteda; % |
|
|
TP53 |
8 |
|
IDH1 or IDH2 |
23 |
|
FLT-3 |
21 |
|
NPM1 |
9.8 |
aIncludes 7 patients with insufficient sample for analysis.
MEDICATION GUIDE
What is VENCLEXTA?
VENCLEXTA is a prescription medicine used:
• to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without 17p deletion, who have received at least 1 prior treatment.