FDA Approves Venclexta (venetoclax) for CLL/SLL and AML
The FDA has approved Venclexta (venetoclax), a BCL-2 inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Additionally, Venclexta is approved in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or those with comorbidities that preclude intensive induction chemotherapy. This approval provides a new oral targeted therapy option for these hematologic malignancies. Venclexta works by inhibiting BCL-2, a protein that promotes survival of cancer cells. The approval underscores the importance of tumor lysis syndrome prophylaxis, as Venclexta can cause rapid tumor reduction. Clinicians should assess patient risk for TLS and provide appropriate hydration and anti-hyperuricemics prior to the first dose.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
VENCLEXTA is a BCL-2 inhibitor. BCL-2 is an anti-apoptotic protein that is overexpressed in some cancer cells, promoting their survival. Venetoclax binds directly to BCL-2, displacing pro-apoptotic proteins and restoring the apoptotic process.
VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is also indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
For CLL/SLL, VENCLEXTA dosing begins with a 5-week ramp-up schedule: Week 1: 20 mg, Week 2: 50 mg, Week 3: 100 mg, Week 4: 200 mg, Week 5 and beyond: 400 mg orally once daily. For AML, the ramp-up is 3 or 4 days: Day 1: 100 mg, Day 2: 200 mg, Day 3: 400 mg, then 400 mg once daily with azacitidine or decitabine, or 600 mg once daily with low-dose cytarabine. Take tablets orally once daily with a meal and water. Do not chew, crush, or break tablets. Provide prophylaxis for tumor lysis syndrome.
Trial data not available in label.
Patients treated with VENCLEXTA may develop tumor lysis syndrome (TLS). Assess patient-specific factors for level of risk of TLS and provide prophylactic hydration and anti-hyperuricemics prior to first dose to reduce risk of TLS.
VENCLEXTA is indicated for CLL/SLL as monotherapy or in combination with acalabrutinib, obinutuzumab, or rituximab. For AML, it is used in combination with azacitidine, decitabine, or low-dose cytarabine in older adults or those with comorbidities.
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