BRUKINSA®


Associated tags: BTK, European, Half-life, Lymphoid leukemia, BeiGene, Pharmacokinetics, BGNE, Health, Biotechnology, Pharmaceutical industry, Patient, SSE, Oncology, Pharmaceutical, Safety, Obinutuzumab, Hematology, Clinical Trials, PFS, Bone marrow, Society, Abstract, Chronic lymphocytic leukemia

Locations: EUROPEAN UNION, SWITZERLAND, UNITED STATES, ICELAND, CHINA, CANADA, NORWAY, AUSTRALIA

Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting

Retrieved on: 
Wednesday, April 24, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Information, Acalabrutinib, Colorectal cancer, BCL2, Follicular lymphoma, Patient, Comparison, TIS, HPK1, Tislelizumab, Lymphoid leukemia, Pharmaceutical industry

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

Key Points: 
  • Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis
    Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)
    BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia
    Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
    Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study
    Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305
    A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors
    Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

GenFleet and BeiGene Enter into Trial Collaboration for a Potentially First-in-class Combination Therapy to Initiate Phase Ib/II Study of GFH009 (CDK9 inhibitor) and BRUKINSA® (zanubrutinib) Treating Diffuse Large B Cell Lymphoma

Retrieved on: 
Thursday, March 28, 2024
B-cell lymphoma, Plasma, Shanghai Cancer Center, Rituximab, Apoptosis, Leukemia, International Journal of Hematology, Patient, Hospital, Doxorubicin, Vincristine, Fudan University, CC3, Standard of care, Acute myeloid leukemia, Epidemiology, Biomedical Chromatography, Prednisone, Peripheral T-cell lymphoma, PARP, National Cancer Center, Therapy, MYC, BTK, Safety, BeiGene, CDK9, Cyclophosphamide, DLBCL, Canadian International Council, MCL1, Follicular lymphoma, Pharmaceutical industry

The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.

Key Points: 
  • The first patient was dosed in the trial led by prominent Henan Cancer Hospital and Fudan University Shanghai Cancer Center.
  • This study will be the first combination trial conducted by a Chinese biotech to combine CDK9 inhibitor and BTK inhibitor targeting DLBCL.
  • The trials of GFH009 treating peripheral T-cell lymphoma and acute myeloid leukemia have entered into phase II stage in China and the U.S. respectively.
  • Epidemiology of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the United States and Western Europe: population-level projections for 2020–2025, Leukemia & Lymphoma, 2021
    3.

BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Thursday, March 7, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, BTK, PFS, Hematology, University, Food, Mantle cell lymphoma, BGNE, Lymphocytosis, Safety, MD Anderson Cancer Center, Chronic lymphocytic leukemia, Lymphoid leukemia, Malignancy, Obinutuzumab, Patient, IRC, Follicular lymphoma, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY ( NCT05100862 ) trial, which is underway.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY ( NCT05100862 ) trial, which is underway.
  • The application for R/R FL was also granted Fast Track Designation and Orphan Drug Designation by the FDA.
  • In a recent presentation, BRUKINSA showed sustained PFS benefit versus ibrutinib in a longer term follow up.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
Thursday, February 29, 2024
Oncology, Health, FDA, Other Science, Science, Pharmaceutical, Biotechnology, Acalabrutinib, BTK, Progression-free survival, Hematology, Physician, Odds ratio, CLL, BGNE, Safety, University, COVID-19, Mayo Clinic, Chronic lymphocytic leukemia, University of Washington, Associate, Patient, Survival, Rituximab, Clutch (eggs), ASCEND, Pharmaceutical industry

The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.

Key Points: 
  • The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival.
  • These data will be presented during the 28th Annual International Congress on Hematologic Malignancies® in Miami from February 29 - March 3.
  • “Head-to-head randomized clinical trials are the gold standard when it comes to evaluating the potential impact of individual treatments for patients.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)

Retrieved on: 
Friday, December 22, 2023
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Exposition, Food, Death, Upper respiratory tract infection, Physician, Lymphocytosis, BGNE, TP53, Hypertension, Mantle cell lymphoma, Neutropenia, Society, ASH, BTK, Patient, Safety, PFS, Pharmaceutical industry

PFS benefit is consistent across multiple sensitivity analyses, demonstrating that PFS advantage with BRUKINSA was primarily driven by efficacy and not tolerability.

Key Points: 
  • PFS benefit is consistent across multiple sensitivity analyses, demonstrating that PFS advantage with BRUKINSA was primarily driven by efficacy and not tolerability.
  • The overall safety and tolerability profile was consistent with previous ALPINE analyses, including persistently lower rates of cardiovascular events reported with BRUKINSA.
  • The most commonly reported treatment emergent adverse events (≥20%) with BRUKINSA were COVID-19-related, neutropenia, hypertension, and upper respiratory tract infection.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023

Retrieved on: 
Tuesday, November 28, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Dexamethasone, Multiple myeloma, BCL2, Safety, PST, Tumor lysis syndrome, BGNE, BTK, Lymphoid leukemia, Bone marrow, Harbor Drive, ASH, US Foods, Patient, Abstract, PFS, TLS, Enterprise Community Partners, Q&A, Acalabrutinib, SSE, Blood, Exposition, CDAC, Cancer, Mental health, Recurrence, Orphan, Society, HIV disease progression rates, Pharmaceutical industry, Vaccine, BeiGene, Hematology

BeiGene has 24 abstracts accepted at ASH, with three abstracts scheduled for oral presentations.

Key Points: 
  • BeiGene has 24 abstracts accepted at ASH, with three abstracts scheduled for oral presentations.
  • “Our data at ASH showcase BeiGene’s leadership in the treatment of blood cancers, with promising clinical advances across our pipeline.
  • BeiGene will host an event in San Diego on Sunday, December 10 at 8:00 pm PST for investors and analysts attending ASH.
  • BeiGene senior management and invited speakers will review BeiGene’s pipeline and highlights of the presented data, followed by a Q&A panel.

BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Friday, November 17, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medicine, Safety, Senior, BGNE, European Commission, BTK, Progression-free survival, Disease, Civil service commission, Patient, PFS, Obinutuzumab, European, DOR, University of Bologna, Follicular lymphoma, SSE, Chronic lymphocytic leukemia, Bone marrow, Initiative, Pharmaceutical industry, Medical device, BeiGene, Hematology

“With this approval, we are excited to announce that BRUKINSA will become available as a treatment option for patients with follicular lymphoma in the European Union.

Key Points: 
  • “With this approval, we are excited to announce that BRUKINSA will become available as a treatment option for patients with follicular lymphoma in the European Union.
  • Responses were durable with 18-month landmark duration of response (DOR) of 69.3% in the BRUKINSA combination arm.
  • BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.
  • “The results from the ROSEWOOD trial demonstrated a significant clinical benefit of BRUKINSA plus obinutuzumab for patients with relapsed or refractory follicular lymphoma.

BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia

Retrieved on: 
Friday, October 20, 2023
Biotechnology, Pharmaceutical, Health, Oncology, National Institute for Health and Care Excellence, SSE, United Kingdom, BGNE, BR, Leeds Teaching Hospitals NHS Trust, TP53, NICE, FCR, NHS, Disease, Leukemia, Healthcare Improvement Scotland, FDG, BTK, Patient, SEQUOIA, Pharmaceutical industry, CLL, EU, BeiGene

“This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.

Key Points: 
  • “This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia.
  • “This decision represents a significant milestone for patients in England and Wales with CLL, the most common form of leukemia in adults,” said Nick York, Patient Advocacy Healthcare Liaison Officer, U.K. Leukemia Care.
  • “Despite continued treatment advances, many patients with CLL will relapse and need additional treatment options.
  • Furthermore, a proportion of patients have a disease which is refractory to initial treatment.”
    BRUKINSA is the third BTKi for CLL to be recommended by NICE for routine commissioning.

BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Friday, October 13, 2023
Biotechnology, Health, Pharmaceutical, Cardiology, Oncology, SSE, European, European Directive on Traditional Herbal Medicinal Products, CHMP, United Kingdom, Committee for Medicinal Products for Human Use, European Commission, Safety, BGNE, European Medicines Agency, Chronic lymphocytic leukemia, Disease, Obinutuzumab, EMA, Initiative, Committee, Hematology, Civil service commission, BTK, Patient, Pharmaceutical industry, Medical device, BeiGene, EU

“Follicular lymphoma remains an incurable disease and an ongoing challenge for healthcare providers.

Key Points: 
  • “Follicular lymphoma remains an incurable disease and an ongoing challenge for healthcare providers.
  • Despite advances in the treatment landscape, patients often relapse and experience shorter response times to subsequent treatments,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
  • Following the CHMP positive opinion, the European Commission will consider BeiGene’s Marketing Application, with a final decision expected within 67 days.
  • BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities in the United States and China.

BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication

Retrieved on: 
Wednesday, July 12, 2023
Biotechnology, FDA, Pharmaceutical, Health, Obinutuzumab, Prescription Drug User Fee Act, BGNE, Arm, Diarrhea, Follicular lymphoma, DOR, Safety, Initiative, Multimedia, SSE, Shanda, HIV disease progression rates, Patient, Risk, European, United Kingdom, Fever, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, Fatigue, Pharmaceutical industry, Medical device, Hematology, BeiGene

BRUKINSA was previously granted Fast Track and Orphan designation for this indication.

Key Points: 
  • BRUKINSA was previously granted Fast Track and Orphan designation for this indication.
  • The FDA has assigned a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act.
  • Safety results from the ROSEWOOD study were consistent with previous studies of both medicines.
  • The global BRUKINSA development program includes more than 4,900 subjects enrolled to-date in 29 countries and regions.