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    Home > Active Ingredient News > Urinary System > Surgery PD-1: After O drug, K drug, I drug, the first indication of T drug was also withdrawn

    Surgery PD-1: After O drug, K drug, I drug, the first indication of T drug was also withdrawn

    • Last Update: 2021-03-22
    • Source: Internet
    • Author: User
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    ▲TG-Bio has joined hands with more than 600 industry colleagues to open in April ▲Recently (March 8, 2021), Roche announced the withdrawal of its PD-L1 antibody Tecentriq from the United States for the second-line treatment of this indication for metastatic urothelial cancer Roche said that this decision was made after consultation with the FDA.

    In the next few weeks, Roche stated that it will cooperate with the FDA to complete the withdrawal procedure for this indication in the United States, and the withdrawal will not affect the use of Tecentriq's other approved indications.

    Roche recommends that patients with metastatic bladder cancer who are currently undergoing Tecentriq treatment should consult medical staff about their continued medication.

    In May 2016, Tecentriq was approved by the FDA for the second-line treatment of patients with locally advanced or metastatic urothelial cancer, becoming the first PD-L1 inhibitor approved by the FDA.

    The accelerated approval is based on a phase II clinical data called IMvigor210 (cohort 2).
    The objective response rate of patients with PD-L1 negative (IC0) is 8%, and the median survival time is 6.
    5 months; and PD-L1 The patients with medium and high expression (IC2/3) were 26% and 11.
    4, respectively.

    In April 2017, the FDA again approved the expansion of Tecentriq's indications for the treatment of locally advanced or metastatic urothelial cancer that cannot be treated with conventional cisplatin chemotherapy.

    One year after Tecentriq received accelerated approval, its two confirmatory trials, IMvigor211 and IMvigor130, successively failed.
    However, at that time, the FDA still maintained approval for the indication.At present, the FDA has approved 2 PD-1 inhibitors and 3 PD-L1 inhibitors for the treatment of metastatic bladder cancer, followed by Tecentriq (atezolizumab, PD-L1 inhibitor), Opdivo (nivolumab, PD- 1 Inhibitor), Bavencio (avelumab, PD-L1 inhibitor), Keytruda (pembrolizumab, PD-1 inhibitor), Imfinzi (durvalumab, PD-L1 inhibitor).

    In addition, NMPA approved Tislelizumab (Tislelizumab, Bezan, PD-1 inhibitor) for the treatment of locally advanced or metastatic urothelial cancer.

    As Tecentriq also withdrew from the second-line treatment of metastatic urothelial cancer, the only PD-L1 inhibitor for the second-line treatment of bladder cancer was Bavencio.
    Last month, AstraZeneca just announced the voluntary withdrawal of Imfinzi for the treatment of urothelial cancer.
    For indications, please see: [Failed to hit the first line, but was implicated in the second line: AstraZeneca withdrew the PD-L1 monoclonal antibody Imfinzi from the US market for bladder cancer].

    Difficulty to replenish the ticket and accelerate the approval is used to encourage product innovation, so that patients can obtain promising therapeutic drugs as soon as possible, especially in the field of oncology.

    FDA official Stein previously stated that the application of accelerated approval in the field of oncology far exceeds other therapeutic areas.
    As the current hottest anti-tumor drug PD-1, it has also greatly benefited from this approval policy.
    Since 2015, PD- 1/L1 inhibitors accounted for half of the accelerated approval of cancer drugs.

    This method of "getting on the bus before making up the ticket" means that there are two results, that is, those who are compensated will be corrected, and the accelerated approval will be promoted to a complete approval, and those that cannot be compensated will be revoked and withdrawn from the market.

    These several PD-1 drugs obtained accelerated approval based on the response rate, and the confirmatory clinical studies of several PD-1 drugs failed to defeat the standard therapies and further verified their efficacy.

    In these short months, O, K, I, and T have successively announced the withdrawal of the indications for the market that rely on accelerated approval, which has shown that the FDA has begun to regain its scientific rigor and scientific rigor in reviewing the “accelerated approval” path.
    The consistent style of strictly observing the rules.In August 2018, the FDA accelerated the approval of Opdivo to treat patients who had received platinum based on the overall response rate (ORR; 12%) and median response rate (DOR; 17.
    9 months) based on the results of the Phase I/II CheckMate-032 trial for SCLC Drug-like chemotherapy and small cell lung cancer that has progressed after receiving at least one other therapy.

    However, bad news followed one after another.

    Three months after Opdivo received accelerated approval to go public, its two confirmatory phase III clinical trials, CheckMate-331 and CheckMate-451, successively failed.

    At the end of last year (December 31, 2020), Bristol-Myers Squibb (BMS) voluntarily announced the withdrawal of Opdivo from the US market for small cell lung cancer (SCLC).

    For details, please see: [Can't escape this catastrophe: Bristol-Myers Squibb (BMS) announced the withdrawal of O-drug small cell lung cancer from the US market] Similarly, the K drug that relied on the accelerated approval of the market was not spared.
    About a week ago (March) On the 1st), Merck announced that it has voluntarily withdrawn its PD-1 monoclonal antibody Keytruda for an indication of metastatic small cell lung cancer (SCLC) in the US market.

    For details, please click: Start of liquidation? Merck’s withdrawal of K drug for small cell lung cancer indications in the United States has fully exposed the shortcomings of the accelerated approval of this new drug approval policy in the withdrawal of AMAG’s Makena, a premature drug, and its withdrawal process has been widely criticized.
    It is believed that the FDA has not achieved the accelerated withdrawal of the accelerated approval of the drug within a reasonable time, because the time when the FDA planned to withdraw Makena has been nine and a half years after it received the accelerated approval.
    In such a long period of time, Makena has been It has basically completed its effective sales cycle and realized commercial benefits.

    This makes people wonder, what is the difference between such an accelerated approval and a thorough approval? The FDA is also aware of these issues.
    Rick Pazdur, director of the FDA's Oncology Center of Excellence, has been calling for a re-examination of this path and overall consideration of the FDA's accelerated plan.

    On November 13-19 last year, the annual meeting of the Friends of Cancer Research Program held a key discussion on the optimization of "accelerated approval".

    Several FDA officials said that they are aware of some of the problems faced by this policy, such as how to better ensure that pharmaceutical companies complete confirmatory tests in a timely manner and how to quickly withdraw products that do not meet the evidentiary standards.

    They also stated: Although accelerated approval is an accelerated regulatory path, it will not change the approval standards for drugs.

    "In order for the accelerated approval program to work, rather than as a lower approval standard, when it is determined based on careful analysis of the data that a confirmatory test fails to prove clinical benefit, or when it takes all available data into account, it is no longer considered When a product has been proven effective for its approved indication, the FDA must be able to withdraw the approval.

    "This concern seems to have spread to the FDA’s accelerated approval of new drugs.
    Last year, BioMarin’s hemophilia A gene therapy Roctavian (valoctocogene roxaparvovec) As well as Intercept's application for accelerated approval of obeticholic acid for the treatment of non-alcoholic steatohepatitis (NASH), a complete response letter was received.
    These drugs involve new alternative endpoints.

    The release of these complete response letters can't help but make people suspect that the FDA may raise the threshold for accelerated approval of new drugs.
    Of course, this may also be just a coincidence.

    The editor concludes that some unexpected problems will inevitably occur during the implementation of any policy, but it is indeed an important regulatory path, especially for the patient population who is expected to benefit from alternative endpoints.

    But there is still a lot of room for improvement.
    We have also seen that the FDA has already begun to act.
    Now, it has begun to operate on PD-1 drugs first. Reference source: 1.
    https://endpts.
    com/roche-withdraws-tecentriq-in-bladder-cancer-amid-fdas-sweeping-review-on-accelerated-approvals/2.
    https:// /view/roche-withdraws-atezolizumab-prior-platinum-treated-metastatic-bladder-cancer-indication-in-the-united-states For more conference details, please click the QR code below! By Aogu Store-around Wenchuang, the interesting soul of biomedicine is here! (Click on the QR code, long press to go) Gathering is a group of fire, the real-name reader group of Bai Aogu, scan the code to add a WeChat editor, please note [Job position + work unit] to facilitate communication and collision of ideas! The copyright statement welcomes personal forwarding and sharing.

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