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    Home > Medical News > Latest Medical News > Bladder cancer immunotherapy! Mercadon Keytruda Treatment NMIBC Enters Priority Review in US

    Bladder cancer immunotherapy! Mercadon Keytruda Treatment NMIBC Enters Priority Review in US

    • Last Update: 2020-05-31
    • Source: Internet
    • Author: User
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    The U.S

    FDA has accepted an application for a supplemental biologics license (sBLA) for the anti-PD-1 therapy Keytruda and granted priority review, The company announced

    The sBLA application approved Keytruda as a single therapy for the treatment of specific high-risk non-muscular leachate bladder cancer (NMIBC) patients, specifically:

    do not qualify for bladder removal or have chosen not to have bladder removal of the card seed no response, high risk, insitually in situ cancer (CIS), accompanied by or not accompanied by nipple-like lesions of NMIBC patients

    FDA's Advisory Board on Oncology and Drugs will meet on December 17 to discuss the sBLA

    Mercadon expects the FDA to make a final review decision in January 2020 based on priority reviews

    the results of this new indication application based on open label, multi-cocination Phase II clinical study KEYNOTE-057 (NCT02625961)

    The study was conducted in high-risk NMIBC patients who did not respond to the current standard therapy, which did not respond to or did not meet or refuse to undergo a curative cystomy, and was divided into two groups of 260 patients: patients with CIS or CIS-plus papillomastography (queue A, n-130), papillomatric lesions and patients without CIS (queue B, n-130)

    Both groups were treated with Keytruda (a fixed dose of 200 mg intravenously every three weeks) until the disease returned, disease progression, unacceptable toxicity, or was treated in patients without progression of the disease until 24 months

    interim analysis data from Group A were presented at the 2018 ESMO Annual Meeting, showing that the total remission (CR) rate was 38.8% (95% CI: 29.4-48.9; n?103) at the 3-month duration of Keytruda treatment

    According to the Kaplan-Meier method, 80% of patients who reached CR at 3 months had CR lasting 6 months or more, and the median remission duration in CR patients had not reached (0 plus to 14.1 plus) at 14.0 months

    In this study, Keytruda's safety was consistent with previous studies of single-drug therapy

    bladder cancer begins with the uncontrolled growth of cells in the bladder, and as more cancer cells appear, they can form tumors and spread to other parts of the body

    Bladder cancer is described according to the extent to which it invades the bladder wall, and NMIBC occurs when the cancer cells do not grow to the main muscle layer of the bladder

    It is estimated that more than 80,000 new cases of bladder cancer will be diagnosed in the United States in 2019, and about 75 percent of bladder cancer patients will be diagnosed with NMIBC

    For high-risk NMIBC patients with no response to the cacao, persistent or recurrent disease, the treatment guidelines recommend a curative cystomy, a surgical procedure to remove the entire bladder, which usually requires the removal of other surrounding organs

    high-risk NMIBC treatment options have traditionally been limited, and many patients rely on surgery after the disease recurs

    In addition, about 40% of high-risk NMIBC patients progress to muscle-soaked disease


    Keytruda is an anti-PD-1 therapy that helps detect and fight tumor cells by improving the body's immune system

    Mercadon has the largest clinical research program for immuno-oncology in the industry

    More than 1,000 clinical trials are currently being studied in a variety of cancer and treatment settings to understand keytruda's role in cancer treatment and to predict what patients can benefit from Keytruda treatment

    In June, Moshadon held its first investor day meeting in five years and said it expected Keytruda to more than double its approval of treatments over the next five years

    Reference source: FDA Grants Priority Review to Merck's Supplemental BiologyS License Application (sBLA) for KEYTRUDA ® (Pembrolizumab) in Certain Patients with High-Risk, Non--Muscle Muscle Cancer (NMIBC)
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