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    Home > Active Ingredient News > Digestive System Information > Merck's anti-PD-1 Keytruda combination therapy receives accelerated FDA approval

    Merck's anti-PD-1 Keytruda combination therapy receives accelerated FDA approval

    • Last Update: 2021-05-22
    • Source: Internet
    • Author: User
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    On May 6, local time, Merck & Co.
    (MSD) announced that the U.
    S.
    Food and Drug Administration (FDA) has accelerated the approval of its anti-PD-1 therapy Keytruda and trastuzumab and fluoropyrimidine and platinum-based chemotherapy Combined, the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma patients.

    Gastric carcinoma is a malignant tumor that originates from the epithelium of the gastric mucosa.
    According to statistics, in 2020, there will be 480,000 newly diagnosed gastric cancer patients in my country, and 370,000 patients will die of gastric cancer! However, due to the limited effectiveness of the first-line therapy of "chemotherapy", the 5-year survival rate for patients with advanced or metastatic gastric cancer is only 5%.

    Therefore, the development of new therapies for gastric cancer is imminent.

    It is reported that the accelerated approval of this therapy is currently the first anti-PD-1 therapy approved for use in combination with trastuzumab and chemotherapy.

    It is also another major breakthrough after Bristol-Myers Squibb's (BMS) PD-1 inhibitor Opdivo combined with chemotherapy was approved for the treatment of gastric cancer patients.

    The therapy mainly blocks the interaction of PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes to enhance the human immune system's ability to detect and destroy cancer cells.

    It is understood that this accelerated approval is based on the support of an ongoing randomized double-blind, placebo-controlled clinical trial KEYNOTE-811.

    The results of the interim analysis showed that of the 264 patients initially randomized into the group, the overall response rate (ORR) of the Keytruda combination therapy group reached 74%, which was significantly better than the control group composed of placebo, trastuzumab and chemotherapy (52 %).

    In the future, it is expected that more new products will usher in the field of gastric cancer treatment.

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