Redefining lymphoma treatment! Takeda Antibody Drug Coupling (ADC) Adcetris (Asili, Vibutusixim) has been officially approved by China!

2020 May 16 News /BioValleyBIOON / - Takeda China recently announced that the Chinese State Drug Administration (NMPA) has formally approved the comfortable advantage ( English trade name: Adcetris, generic name: brentuximabvedotin, injection Cloth rituximab), for the treatment of relapsed or refractory between systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin's lymphoma (HL ) adult patientslymphoma is originated in hematopoietic and lymphoid malignancy is a lymphoma more than 70 subtypes family in generalIn China, it is one of the ten malignant lymphoma tumor, the highest mortality rateData show that China every year about 93000 people werediagnosislymphoma, more than 50,000 people died of lymphomaCurrently, the method of treatment of relapsed or refractory lymphoma is very limitedPrincipal InvestigatorBeijinglymphoma tumorhospital director, research Adcetris registered in China, Professor Zhu said: "We expect Adcetris will provide better treatment options Chinese CD30-positive lymphomassALCL and classical Hodgkin's lymphoma are the expression of CD30 lymphoma subtypesfor decades, treatment options Chinese relapsed or refractory lymphoma patients is very limitedlower overall survival rate of patients, their quality of life has also been the negative impact "
Takeda Chinese president SeanShan expressed:" Adcetris get NMPA Center for Drug Evaluation (CDE) of the priority review in June 2019, it has received formal approval NMPA of the "fast track" approval processshows that Chinese government is determined to accelerate the introduction of highly innovative medicines to Chinese patientswe want to thank NMPA accelerated approval, and the agency is relapsed or refractory lymphoma patients caused due to Takeda's goal is to put our patients do the center of everything, we are committed to using our global R & D capabilities and local carriers to accelerate the pace we bring innovative drugs to meet unmet patient needs China And to support the government's "Healthy China 2030" initiative"
Adcetris approved in China, based on clinical studies SG035-0004, SG035-0003, the data C25007SG 035-0004-study in 58 patients with relapsed or refractory sALCL patients, 97% tumor shrinkage in patients, 5-year survival was 60%SG 035-0003-study in 102 patients with relapsed or refractory cHL patients, 94% of patients with tumors, with a median overall survival (OS) 27.6 out from the history of the month increased to 40.5 monthsC25007 is a single-arm study research for patients with relapsed or refractory cHL (n = 60) stage IV, at least one of these patients received chemotherapy, stem cells and is not suitable
transplantation (SCT) or multidrug chemotherapy; in the present study, patients with objective response rate was 50% (95% CI, 37: 63%)

Adcetris: redefining the benchmark for treating CD30 positive lymphomasAdcetris product is an antibody-drug conjugates (ADC), a monoclonal antibody targeting the CD30 protein and a microtubule disrupting agent (monomethyl auristatinE, MMAE) through a protease-sensitive cross-linking reagent is made, the genetic coupling techniques SeattleChemical company proprietary technologyCD30 protein is a classic Hodgkin's lymphoma (HL) and between systemic anaplastic large cell lymphoma (sALCL) clear markers and AuristatinE tubulin polymerization can be hampered by inhibiting cell divisionAdcetris may be stably present in the blood, after being of a tumor within CD30-positive cells, can release MMAE Adcetris developed by Seattle genetic Chemical Company (SeattleGenetics), Takeda reached a licensing agreement in 2009, won the right to commercialize the drug outside the US and Canada, other countries in the world Up to now, Adcetris has been approved in more than 70 countries around the world, adapt indications as many as six different countries have different indications in the United States, Adcetris has approved six adult indications, including: (1) combined with cyclophosphamide + doxorubicin + prednisone, first-line treatment have not previously received treatment (initial treatment) or other of sALCL CD30 expression in peripheral T-cell lymphoma (PTCL), comprising angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified; (2) + cyclophosphamide + vinblastine, dacarbazine, have not previously received first-line treatment been treated (naïve) the classical III or stage IV Hodgkin's lymphoma (cHL); (3) receiving autologous Stem cell transplantation (ASCT) after consolidation of recurrence or elevated risk of progression cHL; (4) autologous HSCT treatment failure, or is not suitable for autologous HSCT and received at least two kinds of multi-drug chemotherapy failure cHL; (5) previously treated with sALCL treatment failure of at least one multi-drug chemotherapy regimen; inter (6) has previously received systemic treatment of primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30 expression of mycosis fungoides (MF) Currently, Takeda and Seattle genetic Chemical Company is actively promoting a large-scale Phase III clinical development program, the purpose is to Adcetris playing a primary care drugs treat CD30-positive lymphomas, and redefine lymphoma clinical first-line treatment (Biovalley Bioon.com) ORIGINAL: TakedaChinaannouncesADCETRIS (brentuximabvedotin) isapprovedforthetreatmentofadultpatientswithCD30-positiveLymphomas