AbbVie/Roche Venclexta and Gazyva Combination Therapy CLL Canada Approved

This approval, based on data from CLL14 in a critical Phase III clinical study, found that patients receiving venetolaxc and obinutuzumab (ABB) for one year of treatment for the venetolax and obinutuzumab (PFS) achieved significant clinically significant and statistically significant extensions of non-detectable micro-residual disease (MRD) compared to patients treated with standard care regimenitis benzoic acid nitrogen mustard and obinutuzumab (CO)it's worth noting that Venclexta and Gazyva are the first combination of chemotherapy-free, fixed-course combinations approved by Health Canada for first-line treatment of CLLIn the United States, the program was approved by the FDA in May 2019 for first-line treatment of Patients with CLL or small cell lymphoma (SLL)CLL14 is a forward-looking, multi-center, open-label, randomized study conducted in collaboration with the German CLL Research Group (DCLLSG) to assess the efficacy and safety of Patients with comorbidities in the 12-month fixed treatment non-chemotherapy combination VO compared to standard care protocol CO first-line treatmentThe study included a total of 445 patients, all of whom were previously not treated according to the International Symposium on Chronic Lymphocytic Leukemia (iwCLL)In the study, patients received 12 months of fixed-time treatmentThe primary endpoint is the PFS assessed by the investigator according to the iwCLL standard, and the secondary endpoint is the PFS assessed by the Independent Review Committee (IRC), the status of microresidual disease (MRD), the total remission rate (ORR), the full mitigation rate (CR), the total lifetime, the duration of the mitigation, the event-free lifetime, the next CLL treatment time, and safetymedian follow-up for 28 months, the results showed that: (1) the VO programme group had a significantly longer extension, a 65% reduction in the risk of disease progression or death compared to the CO programme group (THE PFS assessed by the investigators was 0.35, 95% CI:0) .23-0.53, p 0.001; PFS evaluated by IRC: HR: HR: 0.33, 95% CI: 0.22-0.51, p 0.001)Over 2 years (i.e1 year after discontinuation of treatment), a higher percentage of patients in the VO programme group remained undeveloped (88.2% vs 64.1%), and the median PFS assessed by the investigators had not yet been reached(2) Compared to the CO programme group, the VO programme group showed consistent clinical benefits at all minor endpoints, including ORR (84.7% vs 71.3%, p0.001) and CR (49.5% vs 23.1%, p 0.001) with at least partial blood cell count recovery(3) After 3 months of treatment, a higher proportion of patients in the VO programme group achieved bone marrow MRD negative (56.9 percent vs 17.1 percent, p0.001) and peripheral blood MRD negative (75.5 percent vs 35.2%, p 0.001) compared to the CO program groupMRD-negative is defined as less than one CLL cell in 10,000 white blood cells(4) The safety of THE VO scheme is consistent with the safety characteristics of the known individual drug, and no new safety signals were found in the combination of drugsThe common 3/4 adverse events in the VO scheme group and VC scheme group were low white blood cell count (52.8% vs 48.1%) and infection (17.5% vs 15.0%), and 2 groups were comparableCLL is a slow-growing type of leukemia, one of the most common leukemia types in adults, characterized by large numbers of immature lymphocytes in the blood and bone marrowCLL accounts for about one-third of newly diagnosed leukemia casesVenclexta's active pharmaceutical ingredient is Venetoclax, an oral B-cell lymphoma factor-2 (BCL-2) inhibitor that plays an important role in apoptosis (procedural cell death) and prevents apoptosis from 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 tumorsVenclexta, developed by AbbVie and Roche, is jointly responsible for the commercialization of the drug in the U.Smarket, and AbbVie is responsible for commercializing the market outside the U.S(branded Venclyxto)Currently, the two sides are undertaking a large clinical project to investigate the treatment of a wide range of blood cancers, including CLL, Hodgkin's lymphoma (NHL), diffuse Large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), and multiple myeloma (MM)Gazyva's active pharmaceutical ingredient is obinutuzumab, the first glycogenized type II anti-CD20 monoclonal antibody targeting CD20 molecules on the surface of B cells that directly induce B-cell deathObinutuzumab is designed to enhance antibody-dependent cytotoxicity (ADCC) and direct cell death induction (Direct Cell Death induction)Obinutuzumab's brand in the U.Sis called Gazyva, and the European brand is called Gazyvarooriginal origin: AbbVie Receives Health Canada approves for the Combination of VENCLEXTA (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocy Leukemiaoriginal title: Leukemia Farewell Chemotherapy! AbbVie/Roche Venclexta and Gazyva combination Canada approved, CLL's first first line no chemotherapy fixed treatment!