Deki Pharmaceuticals submitted an application for the listing of the new Selinexor drug in South Korea

Selinexor was granted orphan drug eligibility in South Korea in October 2020 and was approved by the FDA on December 18 of the same year for multiple myeloma patients who had received at least first-line treatment.
NDA submission is based on positive data from two important STORM and SADAL studies that have shown that selinexor is clinically significant and safe and controllable.
, STORM is an open, single-arm phase 2b clinical study used to evaluate the treatment of rrMM patients with selinexor combined with low-dose dexamison, who received at least four-line treatment, including two protease inhibitors, two immunomodulants, and CD38 monoclonal antibodies.
SADAL is an open Phase 2b clinical study used to evaluate patients with rrDLBCL (including those converted from filthy lymphoma) who have received at least two-line treatment in the past.
Selinexor is the first and only oral selective nuclear output inhibitor (SINE) of its kind and the first FDA-approved drug for the treatment of multiple myeloma and diffuse large B-cell lymphoma.
December 2020, the National Comprehensive Cancer Network (NCCN) incorporated a combination of three selinexor treatments for recurring recurring multiple myeloma into clinical practice guidelines, including SVd (selinexor, bort SPd (selinexor, pomalidomide and dexamethasone) and SDd (selinexor, daratumumab and dexamethasone).
Pharmaceuticals has submitted applications for the listing of new drugs for the treatment of patients with rrMM and rrDLBCL from the Singapore Health Sciences Authority (HSA) and the Australian Medical Supplies Authority (TGA). Dr. Mei Jianming, founder, chairman and chief executive officer of
Deqi Pharmaceuticals, said, "The incidence of hematomas increases with age, and many medical institutions still do not provide adequate treatment options for patients with hematomas such as rrMM and rrDLBCL."
Is pleased to see that selinexor is filing a growing number of listing applications in the Asia Pacific region, including South Korea, and we believe that selinexor, an oral drug, has the potential to expand and improve existing treatments for hematomas, which are important for patients with life-threatening and urgent needs.
" About ATG-010 (selinexor, XPOVIO®) Selinexor is the world's first and only oral SINE compound, developed by Karyopharm Therapeutics.
Pharmaceuticals entered into an exclusive partnership and license with Karyopharm to obtain exclusive development and commercialization interests in ATG-010 (selinexor, XPOVIO®) in a number of Asia Pacific markets including Greater China, Korea, Australia, New Zealand and ASEAN countries.
July 2019, the FDA approved selinexor (XPOVIO®) combined with low-dose dexamisong for the treatment of patients with recurring refractic multiple myeloma (rrMM).
June 2020, the FDA again approved celinexor (XPOVIO®) as a single-drug oral therapy for the treatment of patients with recurring incurable large B-cell lymphoma (rrDLBCL).
addition, a listing license application (MAA) from selinexor (XPOVIO®) has been submitted to the European Medicines Agency (EMA) for conditional approval of atTG-010 (selinexor, XPOVIO®) for rrMM.
In December 2020, the FDA approved a new drug application (sNDA) for SElinexor (XPOVIO®) extension adaptation for the treatment of patients with multiple myeloma who have received at least one line of treatment in the past.
(XPOVIO®) is currently the first and only FDA-approved oral SINE compound for the treatment of multiple myeloma and diffuse large B-cell lymphoma.
addition, selinexor (XPOVIO®) conducted a number of mid- and post-clinical trials for multiple solid tumor adaptations, including liposarcoma and endometrial cancer.
November 2020, Deki Pharmaceutical Partners Karyopharm reported positive data for the 3rd issue of the SEAL study at the 2020 Annual Meeting of connective tissue oncology (CTOS 2020).
SEAL study was a randomized, double-blind, placebo-controlled cross-study designed to compare the efficacy of oral monodride selinexor (XPOVIO®) with placebo in patients with liposarcoma.
addition, Karyopharm recently published an interim invalidity analysis of the completed Phase 3 SIENDO study for patients with endometrial cancer (XPOVIO®), and the Data Safety Monitoring Board (DSMB) recommended that the SIENDO study proceed without any modifications.
results of the SIENDO trial are expected to be released in the second half of 2021.
Deqi Pharmaceuticals is conducting a Phase II registered clinical study (code-named MARCH) on recurring multiple myeloma in China, as well as a phase II registered clinical study (code-named SEARCH) on recurring diffuseric large B-cell lymphoma.
at the same time, Deqi Pharmaceuticals initiated clinical studies (code-named TRUMP) for the treatment of external T-cell lymphoma, NK/T-cell lymphoma (code-named TOUCH) and KRAS mutated non-small cell lung cancer for Asia Pacific high-risk tumors.