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
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
