AbbVie's leukemia drug Venclexta has been fully approved in the United States

recently, the U.S. Food and Drug Administration (FDA) has fully approved AbbVie's Venclexta treatment for acute myeloid leukemia (AML).Venclexta (venetoclax) has been approved as a newly diagnosed AML in adults 75 years of age or older or with comorganism who are unable to use intensive induction chemotherapy in combination with nitrocytosine or testabinine/low-dose agaroseside (LDAC).Approve data based on Phase III VIALE-A and VIALE-C studies and the latest data for phases IB M14-358 and I/II M14-387.In the VIALE-A study, positive overall survival data were observed in the interim analysis, leading to early submissions supporting FDA approval of Vencelxta for AML.The trial showed a 34 percent lower risk of death in patients who were treated effectively with Venclexta with nitrogen hexytosides than in a combined placebo.The average total survival time in patients in the Venclexta group was 14.7 months, while in the placebo group it was 9.6 months.In addition, compared to patients in the placebo group, the total remission rate in the Venclexta group was 37%, with a medium duration of 18.0 months, compared with 18% in the placebo group and a medium duration of 13.4 months.“ AML is a complex and challenging disease that usually has a low survival rate. This approval is significant because the data from our VIALE-A trial show that new diagnosed patients who cannot accept intensive chemotherapy can live longer than other patients after receiving VENCLEXTA gazazine treatment. Mohamed Zaki, vice president and global head of oncology research and development at AbbVie, said.He added: "The trial also provides doctors with more information about patient management - from the start of treatment to the assessment of post-relief response and management. (cyy123.com)original source: