Subject to prior review, lymphoma ADC is expected to be a frontline therapy
January 03, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Seattle Genetics today announced that the FDA has accepted ADCETRIS (brentuximab vedotin) in combination with a chemotherapeutic drug supplemental biologics license application (sBLA) as a front-line therapy for patients with advanced classic Hodgkin's lymphoma. The FDA will prioritize the application. The sBLA is based on the positive results of the ECHELON-1 Phase 3 clinical trial to investigate whether the combination of ADCETRIS and chemotherapeutic drugs can prolong progression-free survival in patients with previously untreated advanced classic Hodgkin's lymphoma.
Lymphoma is a group of cancers originating from the lymphatic system and is divided into two categories: Hodgkin's lymphoma and non-Hodgkin's lymphoma. Unlike other types of lymphoma, classic Hodgkin's lymphoma contains a characteristic cell type called Reed-Sternberg cells. Reed-Sternberg cells express CD30. According to the American Cancer Society, about 8260 cases of Hodgkin's lymphoma were diagnosed in the United States in 2017, and more than 1,000 patients will die. According to the Lymphoma Society, more than 62,000 people (both early and late) are diagnosed with Hodgkin's lymphoma each year, and approximately 25,000 people die each year from this cancer.
ADCETRIS is an antibody drug conjugate (ADC) that links an anti-CD30 monoclonal antibody to a microtubule disruptor MMAE (monomethylauristatin E) via a protease cleavage linkage. The researchers cleverly designed the ADC to exist in a stable form in the blood circulation, but released MMAE when internalized into CD30-positive tumor cells.
ECHELON-1 is a randomized, open-label, multicenter, phase 3 clinical trial designed to evaluate the combination of ADCETRIS+AVD (doxorubicin, vinblastine, dacarbazine) with standard therapy ABVD (doxorubicin, Bora) Compared with the combination of mycin, vinblastine and dacarbazine, it is a front-line therapy for the treatment of advanced classic Hodgkin's lymphoma. The primary endpoint was the independent review agency's assessment of modified progression-free survival (modified PFS) using the Revised Response Criteria for Malignant Lymphoma.
The results of the ECHELON-1 trial showed that the ADCETRIS combination regimen had a statistically significant improvement in improved PFS compared with the control group, as assessed by the Independent Review Facility (hazard ratio = 0.770; p = 0.035). The two-year modified PFS rate was 82.1% in the ADCETRIS group compared with 77.2% in the control group. The mid-term analysis of the overall survival (OS) of the secondary endpoint also favored the validity of the ADCETRIS+AVD group.
â–² Dr. Clay Siegall, President and CEO of Seattle Genetics (Source: Seattle Genetics Official Website)
“The FDA's priority review of supplemental biologics licensing applications is an important milestone in our goal of redefining the frontline treatment of advanced Hodgkin's lymphoma.†Dr. Clay Siegall, President and CEO of Seattle Genetics, said: “We recently ASH in 2017. At the annual scientific meeting of the annual meeting, the main data of the three ECHELON-1 clinical trials were reported and published simultaneously in the New England Journal of Medicine (NEJM). The data show that the protocol containing ADCETRIS is superior to standard therapy. We are working with the FDA to make this bleomycin-free regimen available to newly diagnosed patients with advanced Hodgkin's lymphoma as soon as possible."
Reference materials:
[1] Seattle Genetics Release: FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma
[2] Seattle Genetics official website
[3] WuXi PharmaTech WeChat public number - Courier | Significantly improved PFS, lymphoma innovative drug phase 3 clinical data is good
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