FDA accelerates approval of new indications for targeted cancer drug Venetoxta

, AbbVie and partner Roche announced that theAuthority of theof food anddrugs (http:// (
FDA(http://) has accelerated the approval of a new indication of the anti-cancer drug Venetoxta, a low-level Methylatedor (azacitidine, AZA) or disitamin (decitabine, DAC) or low-dose alyssalysin (LD-AC), first-line treatment of newly diagnosed 2 types of acute myeloid leukemia (AML) adult patientsabout venetoclax
venetoclax is an oral B-cell lymphoma factor-2 (BCL-2) inhibitor, which plays an important role in apoptosis (procedural cell death), prevents apoptosis in some cells, including lymphocytes, and is overexpressed in some types of cancer, associated with the formation of drug resistancevenetoclax aims to selectively inhibit the function of BCL-2, restore the cell's communication system, and allow cancer cells to self-destruct and treat tumorsthe studythis accelerated approval is based on data from two clinical studies (M14-358, M14-387)These studies were conducted in newly diagnosed AML patients, including those who were not eligible for intensive induction chemotherapyin the M14-358 study, the full remission rate (CR) of the Venkxta-AZA scheme group was 37% (n-25/67), the full solution rate (CRh) for partial recovery of blood cell counts was 24% (n-16/67), and the Venclexta-DAC scheme group was 54% (n?7/13), cCLERh 8% (n?13)In the M14-387 study, the CR in the Venclexta-LD-AC scheme group was 21% (n?13/61) and CRh was 21% (n-13/61)In safetystudies, the most common serious side effects of these programs (occurring in at least 5% of patients) include: low white blood cell count with fever, pneumonia, bacteria in the blood, inflammation of tissues under the skin, devices (http:// -related infections, diarrhea, fatigue, bleeding, local infections, multiple infections, organ dysfunction syndrome, and respiratory failure Venetoclax was developed by AbbVie and Roche to commercialize the drug in the U.S market (brand name: Venclexta), and AbbVie is responsible for the commercialization of the market outside the U.S (brand name: Venclyxto) , the two sides are currently conducting a large clinical project to investigate the treatment of a wide range of blood cancers, including CLL, AML, Hodgkin's lymphoma (NHL), diffuse large B-cell lymphoma (DLBCL) and multiple myeloma (MM)