Venclexta + 17p deletion FISH Assay

Disease: Chronic Lymphocytic Leukemia (R/R CLL)

About the Disease:

Chronic Lymphocytic Leukemia (CLL) is the most common type of adult leukemia. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells. In certain cases of CLL, a part of chromosome 17 is lost and along with it (17p deletion), an important gene that controls programmed cell death called p53.

What makes it unique:

VENCLEXTA was first approved under accelerated approval for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) with 17p deletion. VENCLEXTA was approved with a companion diagnostic FISH test for the detection of 17p deletion. 17p deletion, which results in the loss of the TP53 gene, is associated with inferior outcomes in patients treated with chemoimmunotherapy, identifying a patient subset in need of novel therapeutic options. Patients in the VENCLEXTA phase 2 trial were enrolled based on 17p deletion confirmed in the peripheral blood specimens from patients.

Companion Diagnostic:

17p Deletion FISH Assay is a companion diagnostic FDA-approved test that detects 17p deletion.