FDA approved XPOVIO ® treat rrMM patients who have received at least one line of treatment

Oral XPOVIO® is currently the only approved multiple myeloma drug approved for use by co-bozomi (once a week) - the first FDA-approved new mechanism of action multiple myeloma drug since 2016 - FDA approved nearly three months before the PDUFA target date of December 21 - Deki Pharmaceuticals, Inc. ("Deki Pharmaceuticals") Announced that the U.S. Food and Drug Administration (FDA) has officially approved the world's first selective nuclear output inhibitor (SINE) compound XPOVIO® (selinexor, ATG-010) new adaptive drug listing application (sNDA) - in the past with boronicazome and low-dose dexamison treatment of adult multiple myeloma patients who have received at least first-line treatment.
based on the results of the validated BOSTON Phase III clinical trial, the adaptation was approved exactly three months before the PDUFA date (March 19, 2021).
previously, XPOVIO® was approved by the FDA for adult recurring refractic multiple myeloma (rrMM) patients who received at least four-line treatment, including two protease inhibitors, two immunomodulants, and a CD38 monoclonal antibody.
XPOVIO® is the world's first and only oral SINE compound and the only FDA-approved drug for the treatment of multiple myeloma and diffuse large B-cell lymphoma, developed by Karyopharm Therapeutics Inc., researched by Deki Pharmaceuticals.
Pharmaceuticals owns XPOVIO ® development and commercialization licenses for the Asia Pacific region, including China.
December 2020, the National Comprehensive Cancer Network (NCCN® incorporated three XPOVIO® combinations of treatments for recurring multiple myeloma into clinical practice guidelines (NCCN® Guidelines).
Deqi Pharmaceuticals has conducted two XPOVIO®registered Phase 2 clinical trials in China for the treatment of recurring resusctic multiple myeloma (code: MARCH) and recurring resusctic diffuse large B-cell lymphoma (code name: SEARCH), while a randomized, open, multi-center Phase 3 BENCH trial has been approved by the National Drug Administration (NMPA).
Deqi Pharmaceuticals is committed to commercializing XPOVIO® in the Asia Pacific region and has submitted XPOVIO®s New Drug Listing Application (NDAs) for three adaptive disorders to the Singapore Health Sciences Agency (HSA) and the Australian Medical Supplies Authority (TGA), including for the treatment of patients with multiple myeloma who have received at least one line of treatment in the past.
"This is the third XPOVIO® approved for listing, highlighting the clinical potential and broad market prospects of the product," said Dr. Jianming Mei, founder, chairman and CEO of Deqi Pharmaceuticals.
XPOVIO ® provides patients and doctors with multiple myeloma with an original oral drug, the SINE compound, and offers more treatment options for patients who need to meet clinical needs.
our own business foundation and experienced international team, we will launch the XPOVIO ® in the Asia Pacific region as soon as possible after approval for the benefit of rrMM and rrDLBCL patients.
" on phase 3 BOSTON study XPOVIO® the weekly approval of boronitazome and low-dose dexamison (SVd) was based on the results of a multi-center Phase 3 randomized study that evaluated 402 adult patients who had previously received 1-3 lines of treatment for recurring multiple myeloma.
study aims to compare the efficacy, safety, and specific health-related quality-of-life indicators of the weekly XPOVIO® (selinexor) joint weekly boronezomi with low-dose dexamisong and twice-weekly borontzomi and dexamisong (Vd).
end of the study was progress-free lifetime (PFS), and the key secondary endpoints included total remission rate (ORR), incidence of neuropathic diseases, etc.
, the BOSTON study allowed patients in the Vd control group to cross into the SVd group after the independent review committee verified objective (quantitative) disease progression.
BOSTON studies at more than 150 clinical centers around the world.
Although this study was one of the highest proportion of patients with high-risk cytogenetics (-50%) compared to other previously treated lymphoma studies associated with boronitzomi, the results showed that the medium PFS in the SVd group was 13.3. 9 months, compared with 9.5 months in the Vd group, where the middle PFS is 4.4 months more than the latter (risk ratio is 0.70; p=0.0075).
orR in the SVd group was also significantly higher than in the Vd group (76.4% vs. 62.3%, p-0.0012).
, SVd therapy showed consistent and higher orR benefits of PFS in each key subgroup than Vd therapy.
In addition, the following results show that SVd therapy is superior to Vd therapy: SVd therapy has a significantly higher rate of deep remission (defined as ≥ very good partial remission) than Vd therapy (44.6% vs. 32.4%), and the medium remission duration is longer (20.3 months vs 12.9 months).
, 17 percent of patients in the SVd group experienced complete or severe or severe remission, while only 10 percent in the Vd treatment group.
all mitigations have been confirmed by the IRC.
the risk of perovascular neuropathy (PN) in the SVd group was significantly lower than in the Vd group (32% vs. 47%).
addition, the occurrence rate of ≥ 2 PN in the SVd group was significantly lower than in the Vd group (21% vs. 34%).
most common adverse reactions are blood cell reduction, as well as gastrointestinal and systemic symptoms, consistent with other symptoms previously reported in the selinexor study.
most adverse reactions can be controlled after dose adjustment and/or standard supportive care.
most common non-hematological adverse reactions were nausea (50%), fatigue (42%), loss of appetite (35%) and diarrhea (32%), and were mostly level 1 or 2 events.
most common levels 3 and 4 adverse reactions were plate reduction (43%), lymphocytic cell reduction (38%), anemia (17%) and fatigue (13%).
about XPOVIO ® (selinexor, ATG-010) XPOVIO® (selinexor, ATG-010) is the world's first and only oral SINE compound, developed by Karyopharm.
Pharmaceuticals has an exclusive partnership and license with Karyopharm to develop and commercialize four products in the Asia Pacific region, including XPOVIO®.
XPOVIO ® is the first and only oral selective nuclear output inhibitor (SINE) compound of its kind, developed by Dechi Pharmaceuticals in collaboration with Karyopharm.
July 2019, the U.S. Food and Drug Administration (FDA) approved XPOVIO® a joint low-dose dexamisund for the treatment of patients with recurring multiple myeloma (rrMM).
June 2020, the FDA again approved XPOVIO® as a single-drug oral therapy for the treatment of patients with recurring incurable diffuse large B-cell lymphoma (rrDLBCL).
addition, an XPOVIO ® licensing application (MAA) has been submitted to the European Medicines Agency (EMA) for conditional approval of XPOVIO® for the same rrMM adaptation.
December 18, the FDA approved the XPOVIO® Extensioned Adaptation Supplemental New Drug Application (sNDA) 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 oral SINE compound approved by the FDA.
addition, XPOVIO ® conducted a number of mid- and post-clinical trials for multiple solid tumor adaptations, including liposarcoma and endometrial cancer.
November 2020, Deki Pharmaceutical Partner Karyopharm reported positive data for phase 3 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 monodripose XPOVIO® with that of placebo in patients with liposarcoma.
addition, Karyopharm recently published a mid®-term invalidity analysis of the phase 3 SIENDO study for the treatment of endometrial cancer patients, and the Data Safety Monitoring Board (DSMB) recommended that the SIENDO study proceed without any modification as planned.
results of the SIENDO trial are expected to be released in the second half of 2021.
Deqi Pharmaceuticals is conducting XPOVIO® Phase 2 registered clinical studies (code-named MARCH) on recurring multiple myeloma, and phase 2 registered clinical studies (code-named SEARCH) on recurring diffuse large B cell lymphoma.
same time, Deki Pharmaceuticals initiated XPOVIO® clinical studies (code-named TRUMP) for the treatment of exosymetic T-cell lymphoma, NK/T-cell lymphoma (code-named TOUCH) and KRAS mutated non-small cell lung cancer.
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