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    Home > Active Ingredient News > Antitumor Therapy > New lymphoma drug! Roche's first target ADC drug, poly, was approved by the European Union to treat diffuse large B cell lymphoma (DLBCL)!

    New lymphoma drug! Roche's first target ADC drug, poly, was approved by the European Union to treat diffuse large B cell lymphoma (DLBCL)!

    • Last Update: 2020-01-23
    • Source: Internet
    • Author: User
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    January 23, 2020 / BIOON / -- Roche, a Swiss pharmaceutical giant, recently announced that the European Commission (EC) has the conditions to approve the antibody drug coupling compound (ADC) poly (polyatuzumab vedotin piiq), combined with bendamastine and mabthera (general name: rituximab, rituximab) (BR scheme), which is not suitable for hematopoiesis Treatment of adult patients with recurrent or refractory (R / R) diffuse large B-cell lymphoma (DLBCL) after stem cell transplantation In the United States, FDA accelerated the approval of poly plus br in June 2019 for treatment of patients with R / R DLBCL who have received at least two previous therapies In the United States and the European Union, Poly has been granted orphan drug qualification for DLBCL treatment, BTD and prime respectively, which is the first prime qualification obtained by Roche in EU regulation Roche is applying to regulators around the world to bring the new treatment to more patients as soon as possible The accelerated approval of Polivy in the United States and conditional approval of the European Union, based on the complete remission rate observed in randomized controlled clinical trials, further approval will depend on the validation and description of efficacy in confirmatory clinical trials It is worth mentioning that poly is the first chemoimmunotherapy approved to treat R / R DLBCL, which can significantly improve the clinical outcome of patients compared with common treatment schemes DLBCL is an aggressive blood cancer, which is often more difficult to treat every time it recurs Levi Garraway, MD, chief medical officer and head of global product development at Roche, said: "with this approval, patients with relapsed or refractory diffuse large B-cell lymphoma in the EU region will have the opportunity to benefit from this new poly portfolio For patients struggling with this aggressive disease, the prognosis is poor and there are few treatments available We're proud to be able to offer this first treatment to the most needy, "he said Poly was developed by Roche's Genentech using the ADC technology of Seattle genetics company This is a first in class ADC specially targeting CD79b It is made of a humanized anti-cd79b antibody coupled with an anti mitotic agent MMAE It is currently being developed for the treatment of several types of non Hodgkin's lymphoma (NHL) CD79b is highly expressed in most types of B cell NHL, which makes it a promising target for developing new therapies Polatuzumab vedotin targets CD79b and destroys these B cells, minimizing the impact on normal cells while maximizing the destruction of cancer cells Both the FDA accelerated approval and EC conditional approval of Polivy are based on the data of a global Ib / phase II clinical study go29365 In phase II of the study, 80 patients with R / R DLBCL who had been over pretreated were randomly assigned to two protocol groups: (1) polatuzumab vedotin + bendamoxetine + rituximab (PBR); and (2) bendamoxetine + rituximab (BR) The median of previous treatment for these patients was 2 (PBR protocol range 1-7, Br protocol range 1-5) It is worth mentioning that this is the first and only randomized critical clinical study showing a higher remission rate than Br (a commonly used treatment regimen) in patients with R / R DLBCL who are not suitable for hematopoietic stem cell transplantation The results showed that the complete remission rate of PBR group was 40% (n = 16 / 40, 95% CI: 25-57), while that of BR group was only 18% (n = 7 / 40, 95% CI: 7-33) The total survival time (median OS: 12.4 months vs 4.7 months; HR = 0.42) of PBR group was more than doubled compared with br group In addition, in terms of the duration of remission (DOR, the time from the first remission to the deterioration of the disease), PBR group was longer than br group (median dor: 10.3 months vs 4.1 months, HR = 0.44) In terms of safety, the most common adverse events in PBR group and Br group included anemia, thrombocytopenia, neutropenia, fatigue, diarrhea, nausea and fever Original source: European Commission approved Roche's Poly for people with previously treated aggressive lymphama
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