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    Home > Medical News > Medical World News > Innovative mechanism: xpovio, an oral anticancer drug, has won FDA's priority review

    Innovative mechanism: xpovio, an oral anticancer drug, has won FDA's priority review

    • Last Update: 2020-02-21
    • Source: Internet
    • Author: User
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    Recently, karyopharm therapeutics announced that the US FDA has accepted the company's SNDA for xpovio (selinexor) This application seeks to accelerate the approval of xpovio in the treatment of patients with recurrent / refractory diffuse large B-cell lymphoma (R / R DLBCL) These patients received at least two types of pre-treatment The FDA also granted the application a priority review qualification and is expected to respond by June 23 this year Xpovio is karyopharm's "first in class" selective inhibitor of nuclear export (sine), which was approved by FDA last year to treat relapsed / refractory multiple myeloma patients DNA damage is one of the typical characteristics of cancer cells There are some tumor suppressor proteins in cells Their function is to monitor the DNA status in the nucleus If DNA damage is found, they can mediate DNA repair or lead to apoptosis However, these tumor suppressor proteins need to be located in the nucleus to function properly One of the mechanisms by which cancer cells escape tumor suppressor protein monitoring is through overexpression of a nuclear output protein called xpo1 It can transport tumor suppressor proteins from the nucleus to the outside of the nucleus through the nuclear pore, thus removing tumor suppressor proteins from the nucleus Xpovio is a "first in class" xpo1 inhibitor By inhibiting the function of xpo1, the tumor suppressor protein can remain in the nucleus and continue to play a role, thus inhibiting the proliferation of tumor cells Action mechanism of xpovio (photo source: karyopharm official website) This application is based on the results of a phase 2B clinical trial called sadal In this clinical trial of 127 patients with relapsed / refractory DLBCL, the total remission rate was 28.3%, and the complete remission rate was 10.2% The median duration of remission was 9.2 months ▲ results of sadal clinical trial (photo source: karyopharm company website) "We look forward to working with FDA to complete the review process for xpovio's second NDA Patients with recurrent DLBCL who are resistant to multiple therapies still have significant unmet medical needs " Said Dr Sharon shacham, founder, President and chief scientific officer of karyopharm Deqi pharmaceutical obtained the rights and interests of xpovio in the development and promotion of oncology indications in mainland China and Macao in 2018 At present, the company is carrying out a number of registered clinical studies in China reference material: [1] U.S Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO® (Selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Retrieved February 19, 2020, from https://investors.karyopharm.com/news-releases/news-release-details/us-food-and-drug-administration-accepts-karyopharms-supplemental [2] Karyopharm Corporate Presentation Retrieved February 19, 2020, from https://investors.karyopharm.com/static-files/46362c7c-ccfa-4899-b131-86d9198d5640 Note: the purpose of this article is to introduce the progress of medical health research, not to recommend the treatment plan For guidance on treatment options, please visit a regular hospital Original title: express delivery | innovative mechanism: oral anticancer drugs have won the priority review of FDA, and are used to treat refractory large B-cell lymphoma A kind of
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