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    Home > Active Ingredient News > Blood System > Authoritative experts commented that YESCARTA® was first approved by the FDA for second-line LBCL treatment, a milestone new progress in CAR-T therapy!

    Authoritative experts commented that YESCARTA® was first approved by the FDA for second-line LBCL treatment, a milestone new progress in CAR-T therapy!

    • Last Update: 2022-06-16
    • Source: Internet
    • Author: User
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    There are approximately 150,000 new cases of large B-cell lymphoma (LBCL) worldwide each year, and 30-40% of patients still fail to achieve remission after first-line therapy

    .

    Currently, the cure rate of second-line standard treatment for LBCL is only 20%-35%1, and there is a huge unmet clinical need
    .

    On April 1, 2022, local time, the U.
    S.
    Food and Drug Administration (FDA) approved Kite's CAR-T cell therapy drug Yescarta® (Axi-cel) for first-line chemotherapy-immunotherapy refractory or 12 after first-line chemotherapy-immunotherapy.
    Adult patients with LBCL who relapse within a month are expected to open up a new pattern of LBCL treatment

    .

    The results of the ZUMA-7 study facilitated the approval, and the efficacy of Axi-cel was significantly better than that of the standard treatment.
    The new indication for Axi-cel approved by the FDA is based on the results of the ZUMA-7 study 2

    .

    The ZUMA-7 study is a randomized, open-label, global, multicenter Phase III clinical study evaluating the safety of Axi-cel or previous second-line standard therapy in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy sex and effectiveness
    .

    A total of 359 patients were enrolled in the study, with a median follow-up of 24.
    9 months, Axi-cel showed a statistically significant clinical advantage

    .

    Axi-cel prolonged event-free survival (EFS) in LBCL patients by 6.
    3 months (8.
    3 months vs 2.
    0 months) compared with standard care (Figure 1), and the 2-year EFS rate increased by approximately 1.
    5-fold (40.
    5 % vs 16.
    3%) with good safety

    .

    Figure 1 EFS of ZUMA-7 Study Axi-cel VS Standard of Care In addition, ZUMA-7 Study 3 patient-reported results presented at the 2021 ASH meeting showed significant improvement in multiple dimensions with Axi-cel compared to standard of care quality of life in patients with relapsed or refractory LBCL within 12 months of first-line therapy
    .

    The first class 1 recommendation of the NCCN guidelines, Axi-cel has achieved milestone breakthroughs for many times Because of the outstanding efficacy of Axi-cel, it has achieved many milestone breakthroughs in the field of CAR-T therapy in the field of LBCL treatment
    .

    In October 2017, Axi-cel became the world's first CAR-T drug approved for the treatment of adult patients with relapsed or refractory LBCL
    .

    In March 2022, the National Comprehensive Cancer Network (NCCN) included Axi-cel in the category 1 recommendation for diffuse LBCL for "relapsed disease or primary refractory disease within 12 months", and Axi-cel became all types The first CAR-T drug recommended by the NCCN guidelines as a class 1 in cancer treatment 4
    .

    In April 2022, Axi-cel became the world's first and only CAR-T drug approved by the FDA as a second-line therapy for LBCL
    .

    In China, Fosun Kite, as a joint venture between Fosun Pharma Group and Kite in the United States, has obtained Yescarta® technology license and commercialization rights
    .

    In June 2021, the National Medical Products Administration has officially approved the new drug marketing application of the product Yikaida® (Aquilence Injection), becoming the first approved cell therapy product in China for the treatment of patients who have previously received treatment.
    Adult patients with relapsed or refractory LBCL after second-line or more systemic therapy

    .

    YESCARTA®—— CAR-T enters second-line treatment, commented by domestic authoritative experts (in alphabetical order of surname, in no particular order) Prof.
    Hu Yu Yescarta® of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology was approved for second-line LBCL treatment , patients who have not benefited from standard treatment in the past, especially those who are not suitable for transplantation, have ushered in the dawn of cure

    .

    Yescarta® provides a new option for patients with early relapsed and refractory LBCL, opening a new chapter in the treatment of LBCL! Professor Huang Xiaojun, Peking University People's Hospital, Yescarta® was successfully approved by the FDA as a second-line therapy, indicating that the treatment landscape of LBCL is expected to be reshaped
    .

    Yescarta® is one of the most promising immunotherapies in the current tumor treatment field.
    The application of CAR-T in more hematological tumors indicates that more hematological tumor patients can prolong their survival time and improve their quality of life in the future!
    Prof.
    Ma Jun Harbin Institute of Hematology and Oncology Yescarta® has become the world's first CAR-T drug officially approved as a second-line therapy for LBCL, which is a major advance in CAR-T cell therapy

    .

    Significantly superior to the standard of care for patients with relapsed or refractory LBCL over the past three decades, Yescarta® is fundamentally changing the way people think about the treatment of hematological malignancies
    .

    It has great potential to become a new standard of care and has the ability to drive a paradigm shift in the treatment of this patient population
    .

    Prof.
    Depei Wu The First Affiliated Hospital of Soochow University Compared with standard treatment, Yescarta® significantly prolongs the survival of patients with relapsed or refractory LBCL within 12 months after first-line treatment

    .

    CAR-T is a very powerful "weapon" for applicable patients.
    We look forward to its clinical application in the future, and hope that it will bring survival benefits to more LBCL patients!
    Prof.
    Zhao Weili, "All roads lead to targeted diffuse large B-cell lymphoma approaches" in Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, for the treatment of LBCL entering the era of precision medicine

    .

    As a major breakthrough in cellular immunotherapy, CAR-T therapy is a very promising therapy
    .

    Axi-cel has been used around the world for more than 5 years, and it has accumulated a lot of successful experience after its launch in China.
    With the advent of the precision era, more patients will benefit and meet the hope of cure!
    The FDA approval of the new indication of Yescarta® from Peking University Cancer Hospital by Prof.
    Zhu Jun is the long-awaited good news for doctors and patients, which brings better efficacy and better safety to patients with relapsed/refractory LBCL after first-line treatment With the approval and commercial use of CAR-T in China, the medical team has gained more experience in use, improved the whole process management, and helped more patients to meet the hope of cure!
    Expert Profile Prof.
    Hu Yu, Member of the 13th National Committee of the Chinese People's Political Consultative Conference, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, President of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Director of the Institute of Hematology, Huazhong University of Science and Technology, Distinguished Professor of Chinese Medicine Chairman-designate of the Hematology Branch of the Society (leader of the Thrombosis and Hemostasis Group) Member of the Standing Committee of the Internal Medicine Branch of the Chinese Medical Association Vice-chairman of the Hematologist Branch of the Chinese Medical Doctor Association Vice-chairman of the Experimental Hematology Society of the Chinese Pathophysiology Society Committee Member Professor Huang Xiaojun, Chairman of the Hematology Branch of Hubei Medical Association, Doctoral Supervisor, Professor, Peking University People's Hospital, Director of the Institute of Hematology, Peking University People's Hospital, Hematology Expert, Head of the National Clinical Research Center for Hematological Diseases, National Foundation Committee Leader of innovation groups, innovation teams of the Ministry of Science and Technology and Ministry of Education Head of national key disciplines and national key clinical specialties concurrently director of the Standing Committee of the Asia-Pacific Hematology Alliance President of the 4th Chinese Medical Doctor Association Hematologist Branch China Association for the Promotion of International Exchange of Healthcare Hematology Chairman of the Branch Chairman of the 9th Chinese Medical Association Hematology Branch Member of the International Standing Committee of the American Society of Hematology Professor Ma Jun, Member of the Global Committee of the International Organization for Comparative Leukemia Research (IACRLR) Director of the Institute of Hematology and Oncology Chinese Society of Clinical Oncology (CSCO) Chairman of the Supervisory Committee Vice Chairman of the Asian Society of Clinical Oncology Chairman of the Leukemia Expert Committee of the Chinese Society of Clinical Oncology Team Leader Wu Depei, Honorary Consultant of the Nursing Group of the Lymphoma Expert Committee of the Chinese Society of Clinical Oncology
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