First new target drug for myeloma! Xpovio, a nuclear export inhibitor, is marketed in the United States to treat multiple refractory multiple myeloma (mm)
-
Last Update: 2019-07-09
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
July 9, 2019 / BIOON / - karyopharm therapeutics is an oncology centered pharmaceutical company that focuses on the discovery and development of innovative therapies for nuclear transport and related targets for cancer and other major diseases Recently, the company has chosen to include biologics by McKesson, an independent professional pharmacy, into the limited distribution network of the recently approved new anticancer drug xpovio (selinexor), which is expected to be launched in the United States on or before July 10 At the beginning of this month, xpovio was approved by the U.S FDA to be used in combination with dexamethasone in adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four previous therapies and whose disease is difficult to treat at least two proteasome inhibitors (PI), at least two immunosuppressants (IMID) and one anti-CD38 monoclonal antibody Xpovio is a nuclear output inhibitor, targeting the nuclear output protein xpo1 It is worth mentioning that the drug is the first and only FDA approved nuclear export inhibitor, and also the first and only prescription drug approved by FDA for multiple myeloma (mm) patients who are difficult to treat with proteasome inhibitors, immunomodulators and anti-CD38 monoclonal antibodies In addition, xpovio is the first approved drug targeting a new myeloma target (xpo1) since 2015 Currently, the drug is also undergoing accelerated review by the European Drug Administration (EMA) In the United States and the European Union, xpovio has been granted orphan drug qualification and fast track qualification in the United States This approval is based on accelerated approval of remission rate data from the stage IIB storm study, and continued approval of this indication may depend on the validation and description of clinical efficacy in the confirmatory trial Currently, karyopharm is conducting a randomized phase III Boston Study to evaluate the combination of selinexor with Velcade (bortezomib) and low-dose dexamethasone, which will be used as a confirmatory study The FDA's accelerated approval program aims to accelerate the approval of drugs for the treatment of serious diseases and for the filling of major unmet medical needs Storm is an international, multicenter, single group study to evaluate the efficacy and safety of selinexor combined with low-dose dexamethasone In this study, 122 patients have been treated with three or more anti myeloma therapies (including alkylating agent, glucocorticoid, bortezomib, kafezomib, lenalidomide, pomadolamine, anti-CD38 monoclonal antibody) and their myeloma is difficult to treat with glucocorticoid, proteasome inhibitor, immunomodulator, anti-CD38 protein and the last therapy In the study, patients received selinexor (80mg, oral, twice a week) combined with low-dose dexamethasone (20mg, twice a week) until disease progression, death or unacceptable toxicity The results showed that selinexor combined with low-dose dexamethasone had a higher risk-benefit ratio in a subgroup of 83 patients The overall response rate (ORR) of this subgroup was 25.3%, the median time to first response was 4 weeks, and the duration of response was 3.8 months In this subgroup, selinexor has predictable and manageable tolerance, and its safety is consistent with previous studies The active drug component of xpo1-mediated nuclear transport of xpovio is selinexor, which is the first, oral and selective nuclear output inhibitor (sine) compound Through binding and inhibiting the function of xpo1 (also known as CRM1), tumor suppressor proteins accumulate in the nucleus, which will restart and enlarge their tumors Inhibition of the function leads to selective apoptosis of cancer cells, but does not have a significant impact on normal cells At present, karyopharm is also evaluating the selinexor treatment of a series of hematological malignancies in multiple mid-term and late stage clinical studies And the potential of solid tumors, including multiple myeloma (3 clinical studies: Boston, storm, stomp), diffuse large B-cell lymphoma (sadal study), liposarcoma (seal study), endometrial cancer (siendo study), recurrent glioblastoma (King study) Source: xpovio Gamma (selinexor) Available for Order at Biologics by McKesson
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.