Pyrazines

Karyopharm Receives Conditional Marketing Authorization in the United Kingdom (UK) for NEXPOVIO® (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, June 2, 2021
Chemical compounds, Orphan drugs, Drugs, Pyrazines, Chemistry, Antineoplastic drugs, Selinexor, Teratogens, Triazoles, Multiple myeloma, Bortezomib, Takeda Pharmaceutical Company

Adult patients in the trial had a median of seven previous therapeutic regimens, including a median of 10 unique anti-myeloma agents.

Key Points: 
  • Adult patients in the trial had a median of seven previous therapeutic regimens, including a median of 10 unique anti-myeloma agents.
  • Minimal response per IMWG criteria was observed in 16 (13%) patients and 48 patients (39%) had stable disease.
  • NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adultpatients with heavily pretreated multiple myeloma by the European Commission.
  • XPOVIO and NEXPOVIO are registered trademarks of Karyopharm Therapeutics Inc. Velcade is a registered trademark of Takeda Pharmaceutical Company Limited.

Antengene Announces Abstracts on Twelve Clinical Studies of Selinexor Selected by EHA 2021

Retrieved on: 
Wednesday, June 2, 2021
Chemical compounds, Drugs, Orphan drugs, Chemistry, Antineoplastic drugs, Pyrazines, Selinexor, Teratogens, Triazoles, Multiple myeloma, Carfilzomib, Dexamethasone

Once weekly selinexor, carfilzomib, and dexamethasone (XKd) in carfilzomib nonrefractory multiple myeloma (MM) patients.

Key Points: 
  • Once weekly selinexor, carfilzomib, and dexamethasone (XKd) in carfilzomib nonrefractory multiple myeloma (MM) patients.
  • Selinexor containing regimens in patients with multiple myeloma previously treated with anti-CD38 monoclonal antibodies.
  • Ciltacabtagene Autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with 3 lines of prior therapy: A matching adjusted indirect comparison.
  • Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life threatening diseases.

Antengene Announces Fifteen Clinical Studies and Results of Selinexor to be Presented at ASCO 2021

Retrieved on: 
Wednesday, June 2, 2021
Clinical medicine, Chemical compounds, Medicine, Antineoplastic drugs, Orphan drugs, Pyrazines, Selinexor, Teratogens, Triazoles, Multiple myeloma, Dexamethasone, Chemotherapy

Survival among older patients with previously treated multiple myeloma treated with selinexor, bortezomib, and dexamethasone (XVd) in the BOSTON study.

Key Points: 
  • Survival among older patients with previously treated multiple myeloma treated with selinexor, bortezomib, and dexamethasone (XVd) in the BOSTON study.
  • SIENDO/ENGOT-EN5/GOG-3055: A randomized phase 3 trial of maintenance selinexor versus placebo after combination platinum-based chemotherapy in advanced or recurrent endometrial cancer.
  • A phase 1/2 study of selinexor in combination with standard of care therapy for newly diagnosed or recurrent glioblastoma.
  • Selinexor in combination with weekly paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multiarm phase 1b study.

U.S. Food and Drug Administration Grants BCMA CAR-T Cilta-cel Priority Review for the Treatment for Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Wednesday, May 26, 2021
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Drugs, Health sciences, Orphan drugs, Health care, Drug discovery, Medicinal chemistry, Pyrazines, Multiple myeloma, Teratogens, Bortezomib, Immunomodulatory imide drug, Therapy, CARTITUDE-1, Multiple Myeloma, Cilta-cel, Legend Biotech, CARTITUDE-1, MULTIPLE MYELOMA, CILTA-CEL, LEGEND BIOTECH

Priority review is usually granted to investigational therapies which, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

Key Points: 
  • Priority review is usually granted to investigational therapies which, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
  • 2
    Cilta-cel has shown great promise in the treatment of patients with heavily pretreated multiple myeloma according to study findings reported to date.
  • Todays priority review designation marks another significant milestone for this cell therapy, said Ying Huang, PhD, CEO and CFO of Legend Biotech.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Karyopharm Announces Open Enrollment At Participating Hospitals In Europe For A Phase 3 Maintenance Study Evaluating Selinexor In Patients With Endometrial Cancer After Combination Chemotherapy

Retrieved on: 
Wednesday, May 26, 2021
Chemical compounds, Orphan drugs, Clinical research, Design of experiments, Pyrazines, Selinexor, Teratogens, Placebo-controlled study

The KCP-330-024/ENGOT-EN5/SIENDOstudy is an ongoing multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer.

Key Points: 
  • The KCP-330-024/ENGOT-EN5/SIENDOstudy is an ongoing multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer.
  • The study is expected to enroll approximately 248 participants at study sites across the United States, Canada, Israel and Europe.
  • The primary endpoint in the study is progression free survival with the goal of the study demonstrating a hazard ratio of 0.6.
  • XPOVIO and NEXPOVIO are registered trademarks of Karyopharm Therapeutics Inc. Velcade is a registered trademark of Takeda Pharmaceutical Company Limited.

Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the 2021 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021
Drugs, Orphan drugs, Chemical compounds, Antineoplastic drugs, Teratogens, Immunosuppressants, Pyrazines, Selinexor, Daratumumab, Immunomodulatory imide drug, Lenalidomide, XPO1

The data presented this year continue to demonstrate the broad clinical utility of XPO1 inhibition across a growing range of cancer types."\n1.

Key Points: 
  • The data presented this year continue to demonstrate the broad clinical utility of XPO1 inhibition across a growing range of cancer types."\n1.
  • These analyses support the use of the XVd combination for patients with disease refractory to lenalidomide and likely to any IMiD.
  • The data suggest that the regimen was active even in patients with daratumumab-refractory MM.
  • Compared to historical controls who did not receive selinexor, median OS was much longer among these patients.

Legend Biotech Reports New and Updated Data from BCMA CAR-T Program at 2021 ASCO and EHA Meetings

Retrieved on: 
Wednesday, May 12, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Orphan drugs, Health sciences, Health care, Janssen Pharmaceutica, Immunosuppressants, Pyrazines, Teratogens, Bortezomib, Multiple myeloma, Immunomodulatory imide drug, Janssen Biotech, CARTITUDE-1, CARTITUDE-2, Multiple Myeloma, Cilta-cel, Legend Biotech, CARTITUDE-1, CARTITUDE-2, MULTIPLE MYELOMA, CILTA-CEL, LEGEND BIOTECH

In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

Key Points: 
  • In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.
  • In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020.
  • In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Antengene Announces XPO1 Inhibitor Selinexor Prescribed for the First Time in the Pilot Zone of Hainan Province and Authorized to be Expanded Beyond the Pilot Zone for Outpatient Treatment

Retrieved on: 
Thursday, April 29, 2021
Health sciences, Chemical compounds, Antineoplastic drugs, Chemistry, Pyrazines, Selinexor, Teratogens, Triazoles, Treatment of cancer, Therapy

Among these media outlets, People.cn stated: "the first patient with rrMM treated with selinexor in the Pilot Zone responded well to the therapy with his condition already stabilized.

Key Points: 
  • Among these media outlets, People.cn stated: "the first patient with rrMM treated with selinexor in the Pilot Zone responded well to the therapy with his condition already stabilized.
  • Selinexor achieves its antitumor effects by precision targeting the underlying oncogenic pathways, and has a special mechanism of action compared to other approved therapies.
  • Through the rapid clinical adoption of selinexor in Lecheng, Boao, a much-needed new treatment option has been made available to patients with MM in China.
  • Although significant progress has been made in treatment, MM is still incurable, mainly due to primary drug resistance and disease recurrence.

Appili Therapeutics to Present at the Bloom Burton & Co. Healthcare Investor Virtual Conference on Wednesday, April 21st, 2021

Retrieved on: 
Monday, April 19, 2021
Biotechnology, Pharmaceutical, Health, Chemistry, Physical sciences, Ebola, Chemical compounds, COVID-19, Favipiravir, Hydroxyarenes, Isomerism, Pyrazines, XC2, Antiviral drug, Infection

By systematically identifying urgent infections with unmet needs, Appili\xe2\x80\x99s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives.

Key Points: 
  • By systematically identifying urgent infections with unmet needs, Appili\xe2\x80\x99s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives.
  • As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan\xc2\xae / REEQONUSTM (favipiravir) for the worldwide treatment and prevention of COVID-19.
  • Led by a proven management team, Appili is at the epicenter of the global fight against infection.
  • For more information, visit www.AppiliTherapeutics.com .\nBloom Burton & Co. (Bloom Burton Securities Inc.) is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies.

Karyopharm Receives Conditional Marketing Authorization from the European Commission for NEXPOVIO® (selinexor) in Combination with Dexamethasone for the Treatment of Adult Patients with Relapsed and or Refractory Multiple Myeloma

Retrieved on: 
Monday, March 29, 2021
Orphan drugs, Chemical compounds, Drugs, Antineoplastic drugs, Pyrazines, Teratogens, Selinexor, Triazoles, Clinical medicine, Multiple myeloma

The Phase 2b STORM trial (Selinexor Treatment of Refractory Myeloma)was an international, multi-center, single-arm, open-label study which enrolled 123 adult patients (Part 2 of the trial) with heavily pretreated, triple class refractory multiple myeloma.

Key Points: 
  • The Phase 2b STORM trial (Selinexor Treatment of Refractory Myeloma)was an international, multi-center, single-arm, open-label study which enrolled 123 adult patients (Part 2 of the trial) with heavily pretreated, triple class refractory multiple myeloma.
  • Adult patients in the trial had a median of seven previous therapeutic regimens, including a median of 10 unique anti-myeloma agents.
  • Minimal response per IMWG criteria was observed in 16 (13%) patients and 48 patients (39%) had stable disease.
  • NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adultpatients with heavily pretreated multiple myeloma by the European Commission.