On June 8 , the US FDA approved Venetoclax ( VENCLEXTA , AbbVie Inc. and Genentech Inc. ) for patients with chronic lymphocytic leukemia ( CLL ) or small lymphocytic lymphoma ( SLL ), with or without 17p deletion, at least Received a treatment.
Approval is based on MURANO ( NCT02005471 ), a randomized ( 1 : 1 ), multicenter, open-label trial comparing rituximab with venetoclax ( VEN + R ) and bendamustine with rituximab ( B + R & lt ), 389 name CLL patients received at least one previous treatment. VEN + R patients completed the protocol . 5 weeks and the amount of venetoclax treatment regimen, then the start of rituximab, once received daily 400 mg venetoclax , a total of 24 months. Rituximab needs to be treated for 6 cycles on Venetoclax ( Intravenous injection of 375 mg / m2 on day 1 of cycle 1 , 500 mg / m2 of intravenous injection on day 1 of cycles 2-6 , one cycle 28 days). Control group . 6 cycles of B + R & lt (each 28 day cycle 1 and 2 days bendamustine 70mg / m 2 and rituximab above doses and schedules).
Assess progression-free survival ( PFS ). After a median follow-up of 23 months , the median PFS in the VEN + R group was not reached, compared with 18.1 months in the B + R group . The total response rate in the VEN + R group was 92 %, while that in the B + R group was 72 %.
Among the patients treated with VEN + R , the most common adverse reactions (incidence ≥20 %) were neutropenia, diarrhea, upper respiratory tract infection, fatigue, cough and nausea. 64 % of these patients had grade 3 or 4 neutropenia, and 31 % had grade 4 neutropenia. Serious adverse reactions occurred in 46 % of patients, severe infections occurred in 21 % of patients, the most common was pneumonia ( 9 %). Due to the rapid decrease in tumor volume, tumor lysis syndrome ( TLS ) is an important risk factor for Venetoclax treatment. Care should be taken during treatment.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610308.htm
