Venclexta™ - Venetoclax

Venclexta™ - Venetoclax

FDA Approves VENCLEXTA™ (Venetoclax) for the Treatment of Patients with Chronic Lymphocytic Leukemia with 17p Deletion as Detected by an FDA Approved Test, Who have Received at Least One Prior Therapy

On April 11, 2016, the U.S. Food and Drug Administration (FDA) approved VENCLEXTA (Venetoclax) oral tablets under accelerated approval regulations for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion as detected by an FDA approved test, who have received at least one prior therapy. The approved recommended dosage is achieved through a 5-week (WK) ramp-up dosing schedule beginning with 20 mg once daily for 7 days (WK1), followed by a weekly dosage increases (I.e., 50 mg (WK2), 100 mg (WK3), 200 mg (WK4), and 400 mg (WK5)) to the recommended daily dose of 400 mg. This ramp-up is designed to gradually reduce tumor burden (Debulk) and decrease the risk of tumor lysis syndrome (TLS). Patient-specific factors for level of risk of TLS should be assessed and prophylactic hydration and anti-hyperuricemics should be provided to patients prior to first dose of VENCLEXTA to reduce the risk of TLS. VENCLEXTA tablets should be taken with a meal and water at approximately the same time each day. VENCLEXTA should be taken until disease progression or unacceptable toxicity is observed. Monitor patients for TLS and neutropenia during the ramp-up and continued phases of treatment and interrupt dosing or reduce dose for toxicities as outlined in the approved product labeling linked below. Ref. Source 4n.