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    Home > Active Ingredient News > Urinary System > Courier doubles the "cancer-free survival" time of patients with early bladder cancer, and the blockbuster PD-1 inhibitor is approved by the FDA

    Courier doubles the "cancer-free survival" time of patients with early bladder cancer, and the blockbuster PD-1 inhibitor is approved by the FDA

    • Last Update: 2021-10-02
    • Source: Internet
    • Author: User
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    ▎Editor of WuXi PharmaTech Content Team On August 20, 2021, Bristol Myers Squibb (BMS) announced that the US FDA has approved its PD-1 inhibitor nivolumab (nivolumab, the English product name is Opdivo) As an adjuvant therapy, patients with urothelial cancer (UC) who have undergone resection and have a high risk of recurrence, regardless of whether they have received neoadjuvant cisplatin chemotherapy, whether the lymph nodes are involved, or their PD-L1 status
    .

    The press release states that nivolumab is the first PD-1 inhibitor approved for adjuvant treatment of urothelial cancer
    .

     This approval is based on the positive results of the Phase 3 clinical trial CheckMate-274
    .

    The trial reached the primary endpoint.
    The median disease-free survival (DFS) of the nivolumab group was nearly twice that of the placebo group, 20.
    8 months [95% CI: 16.
    5-27.
    6] and 10.
    8 months [95%] CI: 8.
    3~13.
    9]
    .

    In addition, compared with placebo, the risk of disease recurrence or death in the nivolumab group was reduced by 30% ([HR]0.
    70, 95% CI: 0.
    57-0.
    86; P=0.
    0008)
    .

    In patients with tumors expressing PD-L1≥1%, the risk of disease recurrence or death in the nivolumab group was reduced by 45% ([HR]0.
    55, 95% CI: 0.
    39~0.
    77; P=0.
    0005)
    .

    The median DFS in the nivolumab group has not yet reached (95% CI: 21.
    2 to NE; n=140), and the placebo group is 8.
    4 months (95% CI: 5.
    6 to 21.
    2; n=142)
    .

    In terms of safety, 18% of patients had adverse reactions leading to drug withdrawal, and 33% of patients delayed treatment due to adverse reactions
    .

    Serious adverse reactions occurred in 30% of patients
    .

    The most common (≥2%) serious adverse reaction is urinary tract infection
    .

    The most common (≥20%) adverse reactions were rash (36%), fatigue (36%), diarrhea (30%), itching (30%), musculoskeletal pain (28%), and urinary tract infection (22%)
    .

    Urothelial cancer most often originates in cells inside the bladder and is the 10th most common cancer in the world, with approximately 550,000 newly diagnosed cases each year
    .

    In addition to the bladder, urothelial cancer can occur in other parts of the urinary tract, including the ureter and renal pelvis
    .

    Although most urothelial cancers can be diagnosed at an early stage, the recurrence rate and disease progression rate are relatively high
    .

    More than 50% of patients undergoing resection will have disease recurrence
    .

    The prognosis of patients with metastatic cancer is poor.
    When receiving systemic treatment, the median overall survival is about 12 to 14 months
    .

    Mr.
    Adam Lenkowsky, General Manager of Cardiovascular, Immunology and Oncology, Bristol-Myers Squibb USA, said: “Nivolumab became the first PD-1 inhibitor approved for adjuvant treatment of urothelial cancer
    .

    With this progress , We can provide new hope for medical staff and patients
    .

    "Reference: [1] US Food and Drug Administration Approves Opdivo® (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma.
    Retrieved August 20, 2021, from https:// home/20210820005285/en/US-Food-and-Drug-Administration-Approves-Opdivo%C2%AE-nivolumab-for-the-Adjuvant-Treatment-of-Patients-with-High-Risk-Urothelial-Carcinoma Note: This article It is intended to introduce the progress of medical and health research, not a treatment plan recommendation
    .

    If you need treatment plan guidance, please go to a regular hospital for treatment
    .

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