Express . . . GlaxoSmithKline's BCMA antibody coupling drug is expected to be approved after a 12-0 vote by the advisory board.
-
Last Update: 2020-07-17
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
GlaxoSmithKline (GSK), editor of the content team of Wuxi apptec, announced today that the US Food and Drug Administration (FDA) oncology drug advisory committee (ODAC) voted 12-0 to support the company's development of an antibody conjugated drug targeting B-cell mature antigen (BCMA) In the treatment of relapsed / refractory multiple myeloma patients, the benefits outweigh the risks.these patients received at least four previous treatments, including an immunomodulator, a proteasome inhibitor and an anti-CD38 antibody.two members of the committee cannot participate in the final vote.previously, bellantamab mafodotin's biological product license application (BLA) has been granted priority review qualification by FDA.if approved, it may become the first anti BCMA treatment for these patients.multiple myeloma is a malignant hematological cancer caused by malignant transformation of plasma cells in bone marrow.abnormal proliferation of plasma cells can affect the production of normal blood cells, resulting in bone, immune system and kidney damage.although there are a variety of therapies that can effectively treat multiple myeloma, tumor cells usually develop resistance to existing therapies and relapse.therefore, it is very important to develop innovative therapies.belantamab mafodotin is one of the key R & D projects of GSK.it connects humanized anti BCMA antibodies with cytotoxic agents.targeted BCMA, cytotoxic agents were specifically injected into MM cells to kill cancer cells.BCMA is one of the most popular targets in recent years. It is a transmembrane glycoprotein, belonging to the tumor necrosis factor (TNF) receptor superfamily, also known as tnfrsf17 or cd269.the important feature of this protein is that it is highly expressed in all MM cells, and it is not expressed in other normal tissues (except plasma cells).therefore, this target has become a hot target for many pharmaceutical companies and research institutions to develop and treat relapsed / refractory MM patients.previously, bellantamab mafodotin was awarded a breakthrough treatment by FDA.} belantamab mafodotin is a treatment under study developed by GSK (photo source: GSK official website). The proposal is based on the data of dreamm clinical trial project, including the key dreamm-2 clinical study, which included patients who had received a large number of treatment in the past, but their condition continued to deteriorate despite the current standard treatment. the preliminary results of this study were published in December 2019 in Lancet Oncology and served as the basis for bla. Dr Axel HOOS, senior vice president and head of oncology research and development at GSK, said: "we are pleased that the Committee recognizes the potential of belantamab mafodotin to help patients with relapsed / refractory multiple myeloma, which is an incurable disease with limited treatment options. we look forward to working with FDA to complete the review of our biological product license application as soon as possible. "reference: [1] GSK announcements FDA advisory committee votes in favor of positive benefit / risk profile for bellantamab mafodotin for patients with relapsed / reference multiple myeloma. Retrieved July 14, 2020, from note: This paper aims to introduce the progress of medical and health research, not the recommendation of treatment options. if you need guidance on treatment plan, please go to a regular hospital.
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.