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Компания «Рош» подала заявку на регистрацию в России препарата для терапии ранее леченной агрессивной лимфомы
Компания «Рош» подала заявку на регистрацию в России препарата для терапии ранее леченной агрессивной лимфомы
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Аннотация
• Полатузумаб ведотин – первый в своем классе [1]
конъюгат антитело–препарат, нацеленный на белок CD79b, экспрессируемый большинством B-клеток.
• Препарат продемонстрировал улучшение клинических результатов у пациентов с рецидивирующей или рефрактерной диффузной B-крупноклеточной неходжкинской лимфомой (ДBККЛ) по сравнению с широко используемой терапией.
• В США препарат был зарегистрирован в июне 2019 г. по ускоренному протоколу.
конъюгат антитело–препарат, нацеленный на белок CD79b, экспрессируемый большинством B-клеток.
• Препарат продемонстрировал улучшение клинических результатов у пациентов с рецидивирующей или рефрактерной диффузной B-крупноклеточной неходжкинской лимфомой (ДBККЛ) по сравнению с широко используемой терапией.
• В США препарат был зарегистрирован в июне 2019 г. по ускоренному протоколу.
Полный текст
Список литературы
1. Medscape. FDA Approves First Chemoimmunotherapy for R/R Lymphoma Type. https://www.medscape.com/viewarticle/914185
2. Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem 2010; 21: 5–13.
3. ADC Review. What are antibody-drug conjugates? https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/
4. Dornan D et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114: 2721–9.
5. Pfeifer M et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29: 1578–86.
6. FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma. https://www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-pa...
7. FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq...
8. Lyon, France. World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC Press, 2008.
9. Maurer JM et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol 2014; 32: 1066–73.
10. Numbers derived from GLOBOCAN 2018: Estimated cancer incidence, mortality and prevalence worldwide in 2018. http://globocan.iarc.fr
11. Клинические рекомендации. Диффузная В-крупноклеточная лимфома у взрослых. 2016.
[Klinicheskie rekomendatsii. Diffuznaia V-krupnokletochnaia limfoma u vzroslykh. 2016 (in Russian).]
12. Клинические рекомендации по диагностике и лечению диффузной В-крупноклеточной лимфомы взрослых. Под ред. В.Г. Савченко, И.В. Поддубной, 2014.
[Klinicheskie rekomendatsii po diagnostike i lecheniiu diffuznoi V-krupnokletochnoi limfomy vzroslykh. Pod red. V.G. Savchenko, I.V. Poddubnoi, 2014 (in Russian).]
13. Государственный реестр лекарственных средств. https://grls.rosminzdrav.ru/Default.aspx
[Gosudarstvennyi reestr lekarstvennykh sredstv. https://grls.rosminzdrav.ru/Default.aspx (in Russian).]
2. Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem 2010; 21: 5–13.
3. ADC Review. What are antibody-drug conjugates? https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/
4. Dornan D et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114: 2721–9.
5. Pfeifer M et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29: 1578–86.
6. FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma. https://www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-pa...
7. FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq...
8. Lyon, France. World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC Press, 2008.
9. Maurer JM et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol 2014; 32: 1066–73.
10. Numbers derived from GLOBOCAN 2018: Estimated cancer incidence, mortality and prevalence worldwide in 2018. http://globocan.iarc.fr
11. Klinicheskie rekomendatsii. Diffuznaia V-krupnokletochnaia limfoma u vzroslykh. 2016 (in Russian).
12. Klinicheskie rekomendatsii po diagnostike i lecheniiu diffuznoi V-krupnokletochnoi limfomy vzroslykh. Pod red. V.G. Savchenko, I.V. Poddubnoi, 2014 (in Russian).
13. Gosudarstvennyi reestr lekarstvennykh sredstv. https://grls.rosminzdrav.ru/Default.aspx (in Russian).
2. Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem 2010; 21: 5–13.
3. ADC Review. What are antibody-drug conjugates? https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/
4. Dornan D et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114: 2721–9.
5. Pfeifer M et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29: 1578–86.
6. FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma. https://www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-pa...
7. FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq...
8. Lyon, France. World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC Press, 2008.
9. Maurer JM et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol 2014; 32: 1066–73.
10. Numbers derived from GLOBOCAN 2018: Estimated cancer incidence, mortality and prevalence worldwide in 2018. http://globocan.iarc.fr
11. Клинические рекомендации. Диффузная В-крупноклеточная лимфома у взрослых. 2016.
[Klinicheskie rekomendatsii. Diffuznaia V-krupnokletochnaia limfoma u vzroslykh. 2016 (in Russian).]
12. Клинические рекомендации по диагностике и лечению диффузной В-крупноклеточной лимфомы взрослых. Под ред. В.Г. Савченко, И.В. Поддубной, 2014.
[Klinicheskie rekomendatsii po diagnostike i lecheniiu diffuznoi V-krupnokletochnoi limfomy vzroslykh. Pod red. V.G. Savchenko, I.V. Poddubnoi, 2014 (in Russian).]
13. Государственный реестр лекарственных средств. https://grls.rosminzdrav.ru/Default.aspx
[Gosudarstvennyi reestr lekarstvennykh sredstv. https://grls.rosminzdrav.ru/Default.aspx (in Russian).]
________________________________________________
2. Ducry L, Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem 2010; 21: 5–13.
3. ADC Review. What are antibody-drug conjugates? https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/
4. Dornan D et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood 2009; 114: 2721–9.
5. Pfeifer M et al. Anti-CD22 and anti-CD79B antibody drug conjugates are active in different molecular diffuse large B-cell lymphoma subtypes. Leukemia 2015; 29: 1578–86.
6. FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma. https://www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-pa...
7. FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq...
8. Lyon, France. World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC Press, 2008.
9. Maurer JM et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol 2014; 32: 1066–73.
10. Numbers derived from GLOBOCAN 2018: Estimated cancer incidence, mortality and prevalence worldwide in 2018. http://globocan.iarc.fr
11. Klinicheskie rekomendatsii. Diffuznaia V-krupnokletochnaia limfoma u vzroslykh. 2016 (in Russian).
12. Klinicheskie rekomendatsii po diagnostike i lecheniiu diffuznoi V-krupnokletochnoi limfomy vzroslykh. Pod red. V.G. Savchenko, I.V. Poddubnoi, 2014 (in Russian).
13. Gosudarstvennyi reestr lekarstvennykh sredstv. https://grls.rosminzdrav.ru/Default.aspx (in Russian).
Авторы
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