Obinutuzumab

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 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.

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.

Market Access Issues Hindering Specialists’ Use of Advanced Systemics in Lupus Nephritis

Retrieved on: 
Thursday, July 27, 2023
Secukinumab, Obinutuzumab, Tacrolimus, PA, Physician, Rheumatology, Research, Anifrolumab, Patient, Nephrology, Lupus nephritis, Ianalumab, CNI, RealTime, Health insurance, Pharmaceutical industry, Belimumab, LN

Physicians often prescribe alternative treatment options to their LN patients because of high out-of-pocket costs or denied prior authorizations (PA).

Key Points: 
  • Physicians often prescribe alternative treatment options to their LN patients because of high out-of-pocket costs or denied prior authorizations (PA).
  • Rheumatologists and nephrologists are both frustrated with the PA process, managed care hassles, and out-of-pocket costs associated with the recently approved LN drugs.
  • It will be critical for pipeline manufacturers to develop access strategies with payers to ameliorate patient access issues in what is likely to become an increasingly crowded market.
  • Spherix has been tracking the lupus nephritis market quarterly since 2019, prior to the approvals of Benlysta and Lupkynis, to help subscribed clients navigate the rapidly evolving LN market landscape and better understand complicated patient management patterns.

2023 Lupus Nephritis Pipeline Report Reveals 20+ Companies and 25+ Promising Drugs in Development - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 25, 2023
Biotechnology, Pharmaceutical, Health, Tissue, MMF, Therapy, CD20, Horizon Therapeutics, Glucocorticoid, Itolizumab, Roche, Cyclophosphamide, SLE, Risk, Inflammation, Kidney, AstraZeneca, Obinutuzumab, Novartis, Lupus nephritis, III, B cell, Vaccine, Pharmaceutical industry, LN

This report offers comprehensive insights into the Lupus Nephritis pipeline landscape, featuring 20+ companies and 25+ pipeline drugs.

Key Points: 
  • This report offers comprehensive insights into the Lupus Nephritis pipeline landscape, featuring 20+ companies and 25+ pipeline drugs.
  • Lupus Nephritis (LN) is one of the most severe organ manifestations of systemic lupus erythematosus (SLE), an autoimmune disorder causing systemic autoimmunity that damages various tissues and organs.
  • Apart from the aforementioned key players, the report covers various other companies actively engaged in developing therapies for Lupus Nephritis.
  • Market Drivers and Unmet Needs:
    The report identifies key market drivers, influencing factors, and unmet needs in the treatment of Lupus Nephritis.

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.

BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma

Retrieved on: 
Thursday, June 15, 2023
Biotechnology, Health, Science, Research, Oncology, Neutropenia, SEQUOIA, Rituximab, Obinutuzumab, Lymphocytosis, BGNE, Progression-free survival, Lymphoid leukemia, Atrial fibrillation, ICML, Lymphoma, Lenalidomide, Multimedia, Petechia, BTK, PFS, EMA, MRD, Acalabrutinib, SSE, International Conference on Population and Development, Patient, CEST, Lower respiratory tract infection, Bone marrow, Fever, Recurrence, Abstract, Thrombocytopenia, Conference, Pharmaceutical industry, Hematology, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it will present data on its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA® (zanubrutinib) at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place from June 13-17 in Lugano, Switzerland.
  • View the full release here: https://www.businesswire.com/news/home/20230615000227/en/
    BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma - Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene (Photo: Business Wire)
    “The data presented at ICML provide further evidence supporting our confidence in BRUKINSA.
  • The complete response rate for BRUKINSA in combination with obinutuzumab was 39.3% compared to 19.4% for obinutuzumab alone.
  • The most common grade ≥3 adverse events were neutropenia (23.1%), thrombocytopenia (7.7%), lung infection (5.8%) (Abstract #153)

BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress

Retrieved on: 
Friday, June 9, 2023
Oncology, Health, General Health, Clinical Trials, Research, Science, Biotechnology, CLL, SEQUOIA, European Medicines Agency, Abstract, Lymphocytosis, Obinutuzumab, BGNE, Doctor of Philosophy, Chronic lymphocytic leukemia, SLL, Progression-free survival, Lymphoid leukemia, Neoplasm, Bone marrow, BTK, PFS, Acalabrutinib, SSE, Patient, CDAC, Blood, EHA, Prevalence, IGHV, Society, Safety, Pharmaceutical industry, BeiGene

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress.

Key Points: 
  • BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of new data from its broad blood cancer portfolio of approved therapies and promising early-stage pipeline products at the 2023 European Hematology Association (EHA) Hybrid Congress.
  • BeiGene has ten accepted abstracts at EHA, which is taking place from June 8-11 in Frankfurt, Germany.
  • “We are excited to share the latest research from our robust hematology portfolio and pipeline, including new results that further deepen our understanding of BRUKINSA across a number of hematologic malignancies,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene.
  • The European Medicines Agency recently validated BeiGene’s Type II variation application for BRUKINSA for the treatment of adult patients with R/R FL.

AbbVie's VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) Patients

Retrieved on: 
Friday, June 9, 2023
CLL, Neutropenia, Rituximab, Obinutuzumab, Febrile neutropenia, Ars, Royal Melbourne Hospital, European Hematology Association, Diarrhea, German, Grade 3, ABBV, Roche, Aes, Bone marrow, OS, Cytokine, PFS, MRD, Congress, Chlorambucil, AbbVie, Patient, Anemia, Confidence interval, EHA, Hematology, Nausea, Press, Upper respiratory tract infection, Safety, Thrombocytopenia, NYSE, Venetoclax, Pneumonia, Fatigue, Pharmaceutical industry, Fine chemical, Genentech

The results are being presented during oral sessions at the European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.

Key Points: 
  • The results are being presented during oral sessions at the European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.
  • "These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off treatment."
  • New six-year follow-up results from the Phase 3 CLL14 study showcase updated outcomes in previously untreated patients with CLL and co-existing conditions.
  • "These results confirm the treatment benefits of fixed-duration venetoclax and obinutuzumab for previously untreated CLL patients with co-existing conditions."

BeiGene Presentations at the 2023 ASCO Annual Meeting Reinforce Promise Across Oncology Portfolio

Retrieved on: 
Thursday, May 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Abstract (summary), Rituximab, Obinutuzumab, BGNE, EU, Doctor of Philosophy, Hepatocellular carcinoma, Lymphoid leukemia, NA, Lenalidomide, OS, Trae tha Truth, Head, Toxicity, Multimedia, BCLC, Lung cancer, ASCO, PLR, Incidence, SSE, OX40, American Society of Clinical Oncology, Patient, Sorafenib, NLR, Annual general meeting, Bone marrow, Abstract, Society, ORR, Tislelizumab, Pharmaceutical industry, Vaccine, Flour, BeiGene

These results include data for BeiGene’s cornerstone therapies, BRUKINSA® (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor.

Key Points: 
  • These results include data for BeiGene’s cornerstone therapies, BRUKINSA® (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor.
  • These results will be presented on Monday, June 5, as poster presentations from 8:00-11:00 a.m. CT. (Abstracts #4082 and #4083).
  • BGB-11417 monotherapy also showed promising initial efficacy results in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma, with patients achieving responses at lower dose levels.
  • These results will be presented on Monday, June 5, as a poster presentation from 8:00-11:00 a.m. CT (Abstract #7558).