Acalabrutinib

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.

CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Carboplatin, Chemotaxis, Waldenström macroglobulinemia, AstraZeneca, BTK, MCL, Rituximab, B-cell lymphoma, Patient, Ifosfamide, ABC, SWOT, EU4, Etoposide, Follicular lymphoma, Acalabrutinib, Waldenström, RICE, CLL, Axicabtagene ciloleucel, Risk management, Pharmaceutical industry, DLBCL, Phase

The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about CALQUENCE for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the CALQUENCE market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CALQUENCE in DLBCL.

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.

Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

Retrieved on: 
Friday, December 1, 2023
CNS, NYSE, Food, Arrhythmia, Toxicity, BTK, MCL, HSCT, University, Cytopenia, Disease, Tablet, Bleeding, Patient, SLL, Infection, Hematopoietic stem cell transplantation, FDA, DOR, Acalabrutinib, Lymphocytosis, LLY, Chronic lymphocytic leukemia, Eli Lilly and Company, ORR, IRC, Accelerated approval (FDA), CLL, HIV disease progression rates, Lymphoma, Pharmaceutical industry, Pirtobrutinib

INDIANAPOLIS, Dec. 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Key Points: 
  • The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • "The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors.
  • Patients with active central nervous system (CNS) involvement by lymphoma or allogeneic hematopoietic stem cell transplantation (HSCT) within 60 days were excluded.
  • Patients in the efficacy-eligible population had received a median of five prior lines of therapy (range: 2 to 11).

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.

Florida Cancer Specialists & Research Institute Research Breakthroughs Presented at Global Hematology Gathering

Retrieved on: 
Tuesday, December 13, 2022
Chronic lymphocytic leukemia, Role, ASH, AML, American Society of Clinical Oncology, Research, COVID-19, Menin, Hematology, Stanford University, Acute leukemia, Diagnosis, FACP, Prednisone, Health, University of Florida Cancer and Genetics Research Complex, Reversibility, Rituximab, Meta-analysis, Doctor of Pharmacy, Daratumumab, Society, Duke, Tyrosine kinase, ASCO, Hope, News, Quality of life, FCS, BTK, Safety, U.S. News & World Report, Immunotherapy, Drug development, Phase, Physician, Poster, Memorial Sloan Kettering Cancer Center, Covalent bond, Monroe Dunaway Anderson, Harvard University, Pharmaceutical industry, MD, Relapse, Vincristine, Acalabrutinib, Cyclophosphamide, Patient, Doxorubicin, Venous thrombosis

Fort Myers, Florida, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) that is contributing to global advancements in the diagnosis and treatment of blood diseases was presented at the American Society of Hematology (ASH) 64th Annual Meeting and Exposition in New Orleans, Louisiana on Dec. 10 – 13, 2022.

Key Points: 
  • Fort Myers, Florida, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) that is contributing to global advancements in the diagnosis and treatment of blood diseases was presented at the American Society of Hematology (ASH) 64th Annual Meeting and Exposition in New Orleans, Louisiana on Dec. 10 – 13, 2022.
  • “The abstracts being presented with FCS participation represent important, novel research and are considered among the best in the field of hematology,” said FCS President & Managing Physician Michael Diaz, MD .
  • Recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida.
  • Over the past 5 years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation.

RAPT Therapeutics Strengthens Leadership Team with Two New Key Hires

Retrieved on: 
Wednesday, September 28, 2022
Jazz Pharmaceuticals, UNC Gillings School of Global Public Health, Inflammation, Onyx Pharmaceuticals, CCR4, Alopecia areata, Cell biology, Arena Pharmaceuticals, Company, Senior, Growth, Hematology, NDA, Rutgers University, Therapy, Atopic dermatitis, Â, Patient, Regulatory affairs, Cancer, University of North Carolina at Charlotte, Amgen, AstraZeneca, Commercial, RAPT, University of California, San Diego, University of Cambridge, Quality assurance, Denosumab, SAN, Biotechnology, Bavarian Nordic, GLOBE, Marketing, Pharmacia, Procter & Gamble, Genentech, Pleasure, Asthma, University, Pfizer, Chapel Hill, Acalabrutinib, Pharmaceutical industry, Biochemistry, Dermatology

It is a pleasure to welcome both Jennifer and Adnan to the RAPT leadership team at this exciting time of growth for the Company, said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics.

Key Points: 
  • It is a pleasure to welcome both Jennifer and Adnan to the RAPT leadership team at this exciting time of growth for the Company, said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics.
  • Prior to Kronos Bio, she was Head of Global Regulatory Science at Acerta Pharma, a member of the AstraZeneca Group.
  • RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology.
  • RAPT has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively.

858 Therapeutics Expands Board of Directors and Leadership Team

Retrieved on: 
Tuesday, April 5, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Co-promotion, Business development, Therapy, Degenerative disease, NASDAQ, MIT Sloan School of Management, Growth, BMS, Business, IND, Group medical practice in the United States, Biotechnology, NEA, Obinutuzumab, CEO, RNA, Acalabrutinib, SVP, Inflammasome, Amira, Inflammation, LPA1, CA, MBA, BeiGene, BTK, Drug discovery, Fibrosis, VP, Venetoclax, Stanford University, Hematology, Acquisition, Pharmaceutical industry, Fine chemical, Genentech, Sanofi, Oncology, Biology

858 Therapeutics today announced the strengthening of its board of directors and leadership team in preparation for its next stage of growth.

Key Points: 
  • 858 Therapeutics today announced the strengthening of its board of directors and leadership team in preparation for its next stage of growth.
  • To support the advancement of 858 Therapeutics portfolio of small molecule therapeutics directed against oncology targets, the company has named Jane Huang, M.D., as an independent director on the companys Board.
  • In addition, 858 Therapeutics has appointed Sanjay Trehan as SVP of Business Development and has promoted Gretchen Bain, Ph.D., to SVP of Biology.
  • 858 Therapeutics is a biotechnology and drug discovery company developing a portfolio of small molecule therapeutics directed against novel oncology targets.

Jane Huang, M.D., Joins Prelude Therapeutics as President and Chief Medical Officer

Retrieved on: 
Wednesday, March 9, 2022
MCL1, Drug, Private Securities Litigation Reform Act, Company, Research, U.S. Securities and Exchange Commission, CDK9, Cancer, BTK, Bevacizumab, Acalabrutinib, Internal medicine, PRMT5, Woman, Forward-looking statement, Trastuzumab emtansine, Genentech, Risk, Leadership, BRM, Brain, GLOBE, Patient, News, BeiGene, Security (finance), COVID-19, Pharmacology, Venetoclax, Therapy, Rituximab, Stanford University, Goal, Biotechnology, Tislelizumab, Pharmaceutical industry, Prelude, Hematology

WILMINGTON, Del., March 09, 2022 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD) a clinical-stage precision oncology company, today announcedthat Jane Huang, M.D., has been appointed to the newly created position of President and Chief Medical Officer, effective on April 4, 2022.

Key Points: 
  • WILMINGTON, Del., March 09, 2022 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD) a clinical-stage precision oncology company, today announcedthat Jane Huang, M.D., has been appointed to the newly created position of President and Chief Medical Officer, effective on April 4, 2022.
  • Dr. Huang is currently Chief Medical Officer, Hematology, at BeiGene, Ltd., a global, science-driven biotechnology company developing oral small molecules and monoclonal antibodies for cancer.
  • Janes deep experience in oncology drug development and her strategic leadership throughout the lifecycle of multiple products resulting in successful global regulatory approvals will be of great value to Prelude, stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.
  • Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways.