Abbott Test Cleared by FDA as Companion Dx for CLL Drug

• Amanda Bridges
• April 25, 2016
• Drugs

Abbott announced today that the US Food and Drug Administration has granted premarket approved for the company’s Vysis CLL FISH Probe Kit as a companion diagnostic for AbbVie and Genentech’s newly approved chronic lymphocytic leukemia (CLL) drug Venclexta (venetoclax).

Venclexta, a BCL-2 inhibitor, received FDA clearance this week for the treatment of CLL patients with a 17p deletion — which is associated with the loss of the TP53 tumor suppressor gene — and who have failed at least one other therapy. The Vysis test is designed to detect genetic abnormalities in lymphocytes including TP53 deletion, and was approved for CLL prognosis in 2011.

According to Abbott, about 5 percent of CLL patients have a TP53 deletion at diagnosis, but the prevelance of TP53 deletion is estimated to be as high as 50 percent for those with relapsed or refractory disease.

Using Abbott’s test, physicians can now identify whether patients exhibit TP53 deletion in order to determine whether they would benefit from Venclexta.