echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Biochemistry News > Biotechnology News > The U.S. Food and Drug Administration (FDA) approves Opdivo(R) (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of selected adult patients with resectable non-small cell lung cancer

    The U.S. Food and Drug Administration (FDA) approves Opdivo(R) (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of selected adult patients with resectable non-small cell lung cancer

    • Last Update: 2022-05-23
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    SHANGHAI, March 6, 2022 /PRNewswire/ -- On March 4, 2022, Bristol-Myers Squibb (announced that the U.


    In this clinical trial, preoperative use of nivolumab in combination with chemotherapy demonstrated a statistically significant improvement in event-free survival (EFS) compared with chemotherapy alone37 % (HR 0.


    "Considering that a large proportion of patients with resectable non-small cell lung cancer will have a postoperative recurrence occurs, so preoperative treatment is expected to help patients improve their chances of success with surgery while reducing the risk of cancer recurrence


    Nivolumab involves the following warnings and precautions: Serious and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis or hepatotoxicity, endocrinopathy, cutaneous adverse reactions, nephritis with renal insufficiency, and other immune-mediated adverse reactions adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; Mortality is increased, so use outside of controlled clinical trials is not recommended


    Adam Lenkowsky, senior vice president and general manager of Bristol-Myers Squibb's U.


    The application was approved under the FDA's Real-Time Oncology Review (RTOR) pilot program, which is designed to ensure safe and effective treatment for patients as early as possible


    (This indication has not yet been approved in China


    About CheckMate -816

    CheckMate -816 is a global randomized, open-label Phase III clinical study to evaluate the neoadjuvant treatment of nivolumab in combination with platinum-based doublet chemotherapy compared with chemotherapy alone in adult patients with resectable non-small cell lung cancer efficacy, regardless of PD-L1 expression levels


    The primary endpoints of the study were event-free survival as determined by blinded independent central review (BICR) and pathological complete response rate as determined by blinded independent pathological review (BIPR)


    About Lung Cancer

    Lung cancer is the leading cause of cancer death worldwide


    Source: Bristol-Myers Squibb

    The original is abridged

    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.

    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.