Redefining the first-line treatment of lymphoma! Takeda CD30 target drug Adcetris EU approved in the treatment system to become large cell lymphoma (sALCL)

07 April 2020 / Biovalley BIOON / -- Takeda Pharmaceuticals recently announced that the European Medicines Agency (EMA) Committee on Human Medicine products (CHMP) has issued an active review recommending the expansion of Adcetri (brent) Uximab vedotin) marketing authorization, included in: combined chemotherapy protocol CHP (cyclophosphamide and amycin-strong pine), first-line treatment of tumor expression CD30 (CD30 positive) systemic transsexual large cell lymphoma (ALCL) adult patients CHMP's comments will now be submitted to the European Commission for review, which usually makes a final review decision within two months Adcetri is an antibody drug conjugate (ADC) that targets CD30, which is expressed on the surface of a variety of peripheral T-cell lymphoma (PTCL) cells, including ALCL Currently, Adcetri has not approved first-line treatment alCL in Europe positive review of CHMP, based on data from Phase III clinical study ECHELON-2 This is the largest randomized, double-blind Phase III study ever conducted in PTCL patients, with a group of previously untreated CD30-positive PTCL patients (ALCL target ratio of 75% to 5%), and adcetri combined chemotherapy protocol CHP (cyclophosphamide) was evaluated Amine-amycin-strong pine) is used in first-line treatment relative to the currently recognized treatment of PTCL first-line standard care program CHOP (cyclophosphamide and amycin (a ring-like drug) smouldering new alkali and strong pine) efficacy and safety The main endpoint of the study was the Progressless Lifetime (PFS) assessment by the Independent Review Body (IRF) results show that the Adcetri-CHP scheme has achieved a statistically significant improvement in PFS compared to the CHOP scheme (median PFS: 48.2 months (95% CI: 35.2-NE) v 20.8 months 5%CI: 12.7-47.6; IRF:HR s.71.71(95%CI: 0.54-0.93), p.0110, reached the main end of the study In addition, compared with the CHOP scheme, the Adcetri-CHP scheme also showed a statistically significant improvement in the total lifetime (OS) of the key minor endpoints (HR-0.66, p-0.0244), and the two groups were not reached in the two groups In other key secondary endpoints, the Adcetri-CHP program also showed statistically significant advantages, including: PFS in ALCL patients, full remission rate (CRR: 68% v 56%, p-0.007), objective mitigation rate (ORR:83% v 72%, p-0.003) In this study, the Adcetri-CHP scheme is comparable to the CHOP scheme and consistent with the established safety of the Adcetri and chemotherapy combination symbling protocols Adcetri is an antibody conjugate dictation drug (ADC) made from a monoclonal antibody targeting the CD30 protein and a microtube destroyer (monomethylauritatin E, MMAE) through a protease-sensitive crosslinking agent that is proprietary to Seattle Genetic
CD30 protein is a clear marker of classic Hodgkin's lymphoma (HL) and systemic lysomal large cell lymphoma (ALCL), and Auritatin E can block cell division by inhibiting the polymerization of microtubule proteins Adcetri is stable in the blood and releases MMAE after being cd30-positive tumor cell internalization Adcetri was developed by Seattle Genetics, a Seattle-based genetic , and Takeda reached an authorization agreement in 2009 that granted the drug commercialization rights in other countries around the world, except the United States and Canada To date, Adcetri has been approved by more than 70 countries worldwide for the treatment of recurrent or refractory Hodgkin's lymphoma (HL) and ALCL In the United States, Adcetri has been approved by the FDA for six adult indications , Takeda and Seattle Genetics and are actively promoting a large phase III clinical development program aimed at making Adcetri a basic care drug for CD30-positive lymphoma and redefining the clinical first-line treatment of lymphoma (biovalleybioon.com) original origin: Takeda Receive Poitive CHMP Opinion for ADCETRIS ® (Brentuximab vedotin) in combination with CHP (Cyclophophamide, Doxorubicin and Prednione) for The End Of The Adult Patient
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