Venclexta Approval History
Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion.
The FDA granted accelerated approval of Venclexta based on efficacy data from an open-label, multicenter clinical trial of 106 previously-treated CLL patients with 17p deletion. Patients received daily Venclexta under a weekly ramp-up schedule and continued treatment until disease progression or unacceptable toxicity. Results showed an overall response rate (ORR) of 80 percent.
Venclexta is an oral tablet administered daily according to a dosing schedule, and swallowed whole with a meal and water.
The most common side effects reported during clinical trials include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infections, thrombocytopenia and fatigue.
Development History and FDA Approval Process for Venclexta
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