New York, NY (June 8, 2018) – The U.S. Food and Drug Administration (FDA) announced today it has approved the use of venetoclax (VENCLEXTA) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, after one prior treatment.
This approval is based on data from a clinical trial evaluating venetoclax in combination with rituximab (Rituxan). The trial compared venetoclax plus rituximab with bendamustine plus rituximab in CLL patients who had received at least one prior line of therapy. Patients in the venetoclax arm completed a five-week ramp-up schedule before receiving 400 mg of venetoclax once daily for 24 months. Rituximab, which was administered after the ramp-up schedule, was given for six 28-day cycles (375 mg/m2 intravenously on cycle one day one and 500 mg/m2 intravenously on day one of cycles two through six).
“Today’s approval offers patients with CLL and SLL a new treatment option and a new opportunity for hope,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We applaud the FDA, AbbeVie Inc., Genentech Inc., and most importantly the patients who made this approval possible and for their roles in advancing progress in the treatment of CLL and SLL.”