Redefining the first-line treatment of lymphoma! Takeda CD30 target drug Adcetris is approved by the European Union to treat inter-system largecell lymphoma (sALCL)!

2020 May 15 News /BioValleyBIOON / - Takeda Pharmaceuticals (TakedaPharma) today announced that the European Commission (EC) has approved the expansion of Adcetris (brentuximabvedotin) conditional marketing authorization to include: combination chemotherapy CHP (doxorubicin + cyclophosphamide + prednisone), first-line treatmenttumorexpress CD30 (CD30-positive) between systemic anaplastic large cell lymphoma (sALCL) in adult patientsThe approval, applies to all EU member states, Norway, Liechtenstein, IcelandIt is worth mentioning that, Adcetris is a targeted drug in decades and only approved first-line treatment of sALCLAdcetris is a CD30 antibody drug conjugate (ADC) targeting, CD30 expression in a variety of peripheral T-cell lymphoma (PTCL) cell surface, including sALCL, which is a subtype of PTCLlong time, the clinical outcomes of patients with sALCL has been very poor, many patients do not reach the standard of care for long-term survival or remissionClinical data show that, compared with standard CHOP therapy group, Adcetris + CHP scheme patients achieved impressive clinical outcomes, while maintaining comparable securityFor not previously received treatment sALCL patients, Adcetris + CHP scheme will bring a much-needed first-line treatment optionThe approval, ECHELON-2 data based on the phase III studyThis is the largest randomized undertaken to date in PTCL patients, double-blind Phase III study, the group that CD30-positive PTCL patients not previously treated (sALCL target ratio of 75% ± 5%), a joint assessment of the Adcetris with respect to the currently accepted standard first-line treatment of PTCL care regimen of CHOP (cyclophosphamide + doxorubicin [an anthracycline drugs] when chemotherapy CHP (cyclophosphamide + doxorubicin + prednisone) for the first-line treatment + vincristine + prednisone) efficacy and safetyThe primary endpoint of the study was an independent review body (IRF) assessment of progression-free survival (PFS)results showed that study met its primary endpoint: The Independent Review Committee (IRF) examine, in a population of patients intention to treat (ITT) compared with CHOP regimen, Adcetris + CHP program enables PFS to achieve statistical significance significantly improved (median PFS: 48.2 months [95% CI: 35.2-NE] vs20.8 months [95% CI: 12.7-47.6]; IRF: HR = 0.71 [95% CI: 0.54-0.93], p = 0.0110) addition, compared with CHOP regimen, Adcetris + CHP program key secondary endpoints overall survival (OS) also showed significant statistically significant improvement (HR = 0.66, p = 0.0244), the current 2 the median OS did not reach Other key secondary end points, Adcetris + CHP program also showed a significant advantage statistically significant, including: sALCL patients with PFS, complete response rate (CRR: 68% vs56%, p = 0.007), objective response rate (ORR : 83% vs72%, p = 0.003) this study, Adcetris + CHP scheme and CHOP regimen having comparable safety and chemotherapy combination regimen with Adcetris and established security agreement global pharmaceutical business tumor president TeresaBitetti Takeda, said: "The European Commission approved Adcetris first-line treatment sALCL, this is an important milestone for patients diagnosed with this devastating disease Adcetris decades the first and only approved a first-line treatment sALCL targeted therapies Takeda has always been firmly committed to providing life-changing treatment options for cancer patients worldwide, and we are excited about the opportunity this new the program to the European community's lymphoma "
Adcetris is an antibody-drug conjugates (the ADC), a monoclonal antibody, and a microtubule disrupting agents (meth auristatinE from a single targeting CD30 protein, MMAE) coupled together by means of a protease-sensitive crosslinking agent, the genetic coupling techniques Seattle Chemical company proprietary technology CD30 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 division Adcetris 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 worldwide for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and sALCL In the United States and the European Union, Adcetris has been approved for six indications in adults 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 a (Biovalley Bioon.com) ORIGINAL: EuropeanCommission app rovesADCETRIS® (brentuximabvedotin) forTreatmentofAdultPatientswithPreviouslyUntreatedSystemicAnaplasticLargeCellLymphoma