echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > The FDA today accelerated the approval of the first antibody conjugate drug targeting CD19, and it has been approved for clinical trials in China

    The FDA today accelerated the approval of the first antibody conjugate drug targeting CD19, and it has been approved for clinical trials in China

    • Last Update: 2021-05-09
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    ADC Therapeutics announced that the US FDA has accelerated the approval of the CD19-targeting antibody-conjugated drug Zynlonta (loncastuximabtesirine-lpyl) as a monotherapy for adult patients with relapsed/refractory large B-cell lymphoma.
    These patients have received at least two Systemic therapy.
    The press release states that this is the first antibody-conjugated drug (ADC) that has been approved by the FDA to target CD19.
    It is worth mentioning that Overland Pharmaceuticals, supported by Hillhouse Capital, has obtained the exclusive license of ADC Therapeutics through the establishment of a joint venture company Overland ADCT BioPharma with ADC Therapeutics, and has the ability to develop and promote this in Greater China and Singapore.
    The rights and interests of an innovative ADC.

    ADC Therapeutics announced that the US FDA has accelerated the approval of the CD19-targeting antibody-conjugated drug Zynlonta (loncastuximabtesirine-lpyl) as a monotherapy for adult patients with relapsed/refractory large B-cell lymphoma.
    These patients have received at least two Systemic therapy.
    The press release states that this is the first antibody-conjugated drug (ADC) that has been approved by the FDA to target CD19.
    It is worth mentioning that Overland Pharmaceuticals, supported by Hillhouse Capital, has obtained the exclusive license of ADC Therapeutics through the establishment of a joint venture company Overland ADCT BioPharma with ADC Therapeutics, and has the ability to develop and promote this in Greater China and Singapore.
    The rights and interests of an innovative ADC.

    Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin’s lymphoma, and it is a rapidly progressing aggressive disease.
    More than 40% of first-line DLBCL therapies fail, and the prognosis is poor for patients whose first-line therapy fails.
    Therefore, they urgently need effective and innovative therapies.

    Antibody-conjugated drugs combine with specific antigens on the surface of cancer cells to deliver the toxic compounds carried into the cells, thereby killing cancer cells while avoiding damage to healthy cells.
    Zynlonta's design conjugates a humanized anti-CD19 monoclonal antibody to a unique cytotoxin called a pyrrolobenzodiazepine (PBD) dimer.
    CD19 is a specific antigen expressed on the surface of B cells and is the target of a variety of CAR-T therapies.
    After PBD enters the cell, it binds to the DNA irreversibly, and efficiently cross-links the two strands of the DNA double helix, preventing the separation of the DNA strands, and ultimately leading to the death of the cell.



    The FDA approval is based on a single-arm phase 2 clinical trial called LOTIS-2.
    145 patients with relapsed/refractory DLBCL received Zynlonta treatment.
    These patients had previously received at least two therapies, some of them received Through the treatment of stem cell transplantation therapy and CAR-T therapy.
    The test results showed that Zynlonta achieved an overall response rate (ORR) of 48.
    3% (70/145), of which the complete response rate was 24.
    1%.
    Moreover, 15.
    2% of patients had stable disease.



    The latest data show that the median duration of remission for patients reached 12.
    58 months, and the median duration of remission for the subgroup of patients who achieved complete remission reached 13.
    37 months.



    "FDA approval of the listing of Zynlonta is an important advancement for DLBCL patients.
    " said Mr.
    Chris Martin, CEO of ADC Therapeutic.
    "We extend our best to the patients participating in clinical trials, their families, researchers and our employees.
    My sincerest thanks for making this important milestone possible.
    "

    In China, according to the information on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, the loncastuximabtesirine for injection jointly declared by ADC Therapeutics and Linglu Pharmaceuticals has obtained an implied license for a clinical trial, which is expected to compete with Bruton's kinase.
    (BTK) inhibitors are used in clinical trials to treat patients with relapsed/refractory DBCLC or mantle cell lymphoma.
    ADCTherapeutics also plans to carry out a number of clinical trials to further explore the potential of this innovative ADC as a part of combination therapy, second-line and first-line treatment of DBCLC patients.

        



    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.
    Related Articles

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent Echemi's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.