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    Home > Active Ingredient News > Urinary System > Express treatment of bladder cancer, "first-in-class" antibody-conjugated drugs expand indications

    Express treatment of bladder cancer, "first-in-class" antibody-conjugated drugs expand indications

    • Last Update: 2021-08-10
    • Source: Internet
    • Author: User
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    ▎The content team editor of WuXi AppTec today, Seagen and Astellas jointly announced that the US FDA has approved the company’s antibody-conjugated drug (ADC) Padcev (enfortumab vedotin-ejfv) for extended indications for the treatment of previous Patients with locally advanced or metastatic urothelial cancer who have received at least one pre-treatment, but are not suitable for receiving cisplatin-containing chemotherapy
    .

    The press release states that this is the first therapy approved by the FDA for this patient group
    .

    The FDA also converted the previous accelerated approval into full approval based on the data from Padcev's Phase 3 clinical trial EV-301
    .

    In 2020, approximately 580,000 people worldwide will be diagnosed with bladder cancer
    .

    Urothelial cancer accounts for 90% of all bladder cancers and can also occur in the renal pelvis, ureter, and urethra
    .

    The press release pointed out that about half of patients with advanced bladder cancer cannot receive cisplatin-containing chemotherapy.
    They usually receive first-line immunotherapy.
    However, if there is no response to immunotherapy or disease recurrence, their treatment options are limited and the prognosis is poor
    .

    Padcev is an antibody conjugate drug that conjugates anti-nectin-4 monoclonal antibody and microtubule inhibitor
    .

    Nectin-4 protein is a cell adhesion molecule highly expressed in urothelial carcinoma
    .

    Based on the response rate data, this therapy received accelerated approval from the US FDA in December 2019 to treat patients with locally advanced or metastatic urothelial cancer
    .

    These patients have been treated with cisplatin-containing chemotherapy and PD-1/PD-L1 inhibitors
    .

    The approval of the extended indications is based on the positive results obtained by Padcev in the second cohort of patients in the pivotal phase 2 clinical trial EV-201
    .

    The results of the trial showed that in patients with locally advanced or metastatic urothelial cancer who had received PD-1/PD-L1 inhibitor treatment and were not suitable for cisplatin-containing chemotherapy, when the median follow-up time was 16 months, they received Padcev The objective response rate of treated patients was 51% (95% CI: 39.
    8, 61.
    3)
    .

    The median duration of response was 13.
    8 months (95% CI: 6.
    4, not yet reached)
    .

    The conversion of Padcev’s accelerated approval to full approval is based on positive data from the Phase 3 clinical trial EV-301
    .

    This data has been published in the New England Journal of Medicine.
    Compared with chemotherapy, Padcev extended the patient's overall survival by 3.
    9 months
    .

    "For locally advanced or metastatic patients who have received immunotherapy but cannot receive cisplatin chemotherapy, Padcev is the first FDA-approved therapy
    .

    " said Dr.
    Roger Dansey, Chief Medical Officer of Seagen, "because of the FDA's real-time oncology review Evaluation procedures, we can bring it to these patients as soon as possible, they have limited treatment options due to age or comorbidities
    .

    "Reference: [1] US FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer.
    Retrieved July 9, 2021, from https:// /news/home/20210709005414/en Note: This article aims to introduce the progress of medical and health research, not a recommendation for treatment plans
    .

    If you need guidance on treatment plans, please go to a regular hospital
    .

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