Roche submits application to FDA for new drug in Venclexta

today, Roche's Genentech announced it had submitted a supplementto-
new drug(sNDA) to theFDAif the application is approved, Venclexta may be treated with the primary treatment of acute myeloid leukemia (AML) with a combination of demethylateddrug(or low-dose alyssalysine (LDAC) treatmentVenclextaVenclexta, a new drug developed by Genetek in collaboration with AbbVie, is a small molecular inhibitor that selectively binds to b-cell lymphoma factor 2 (BCL-2) proteinBCL-2 plays an important role in apoptosis (procedural death)Excessive expression of BCL-2 in AML has been shown to be associated with the disease's resistance to specific therapies, while blocking the BCL-2 protein may restore the cell's "signal system" and allow cancer cells to self-destroy and fight cancerrelated studiesthe application was submitted based on two clinical
trial(results of the 1b Phase M14-358 study (NCT02203773) to assess the use of Venclexta as a combination of combination therapy and the demethylated drug Azacitidine or decitabine, The 1b/2 Phase M14-387 study (NCT02287233) is designed to assess the effectiveness and safety of Venclexta as a combination of combination therapy and LDAC for patients aged 60 and over who are not treated but not suitable for high-dose chemotherapytwo studies were clinical dose increase syltos and amplification studies, and the end of the study included full remission rates (with or without full blood count recovery, CR/CRi), OS (total lifetime) and safetyThe results of the M14-358 trial showed that The CR/CRi of Venclexta (400 mg) was 73% The median OS in all Venclexta dose groups was 17.5 months (95% CI: 12.3 - not yet reached) The results of the M14-387 trial showed that the CR/CRi in patients with Venclexta (600 mg dose) was 62% The median OS is 11.4 months (95% CI: 5.7-15.7)