Axicabtagene ciloleucel

Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy

Retrieved on: 
Tuesday, January 30, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Hospitals, Standard of care, B-cell lymphoma, Survival, Knowledge, Cell, MD, Patient, Leukapheresis, Axicabtagene ciloleucel, Stanford University, SVP, Food, Physician, Doctor of Philosophy, TAT, Pharmaceutical industry

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel).

Key Points: 
  • Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel).
  • With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days.
  • The cells are removed through leukapheresis and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR).
  • The CAR T-cell therapy process is a continuous one, from leukapheresis to the delivery of the final product, so the timing and scheduling of this process are critical to the supply.

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.

Analyses of Kite’s Yescarta® CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas

Retrieved on: 
Tuesday, December 12, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Arm, Safety, Senior, Hope, Hypogammaglobulinemia, Ageing, ASH, University, EFS, B-cell lymphoma, Patient, Abstract, PFS, DOR, Follicular lymphoma, Lymphoma, DSS, Subgroup analysis, Standard of care, ORR, MD, Survival, Death, HR, Doctor of Philosophy, MD Anderson Cancer Center, Cancer, SOC, OS, Knowledge, Society, Confidence interval, Pharmaceutical industry, Axicabtagene ciloleucel

In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential.

Key Points: 
  • In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential.
  • Yescarta had long-term LREFS in a substantial proportion of patients, with a five-year rate of 34% (57% among patients who achieved a CR).
  • Among patients who had a CR to therapy, the leading risks of death were reasons other than progression or adverse events after month 24 post-infusion.
  • “We are encouraged by these data, particularly the continued durable response and long-term survival in these patient populations that speak to the potentially curative benefit of this therapy.

Long-Term Data for Kite’s Yescarta® CAR T-Cell Therapy Presented at ASH 2023 Demonstrate High Rate of Durable Response in Patients With High-Risk Large B-Cell Lymphoma

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, BCL2, Fever, MYC, Progression-free survival, ASH, Aes, CRS, EFS, B-cell lymphoma, Headache, Cytopenia, Non-Hodgkin lymphoma, Patient, Abstract, PFS, DOR, BCL6, Histology, ORR, MD, Survival, Doctor of Philosophy, Drug, Society, OS, Confidence interval, Axicabtagene ciloleucel, SVP, Cytokine release syndrome, Pharmaceutical industry

“Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies,” said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center.

Key Points: 
  • “Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies,” said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center.
  • “This is particularly true of patients with double- or triple-hit histology, who have a median survival of under a year with standard treatment.
  • Prolonged cytopenias of any grade (present Day ≥30 post-infusion) occurred in 9 patients (n=7 neutrophil count decreased) and were resolved by data cutoff.
  • Among treated patients, the in vivo Yescarta expansion and persistence profiles are consistent with previous observations.

CARsgen Announces Formation of its Clinical Advisory Board

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Monday, November 20, 2023
Dexamethasone, Experiment, Teaching hospital, Patient, Strategic planning, Bortezomib, Vall d'Hebron University Hospital, Cancer, Ernest Beutler, TCO, Doctor of Philosophy, Knowledge, Axicabtagene ciloleucel, University of Miami, Multiple myeloma, Douglas E. Lynch, R.J. Corman Railroad Group, University, ESMO, Harvard Medical School, Regorafenib, Biomarker, Principal, Translation, Vall, MD Anderson Cancer Center, Lenalidomide, Therapy, National Cancer Institute, Dana–Farber Cancer Institute, MGUS, Publication, Drug development, NCI-designated Cancer Center, The Lancet, Research, Lymphoid leukemia, NCI, CD19, MRD, FDA, MD, Survival, Lymphoma, Pharmaceutical industry, Daratumumab, Medicine, Immunotherapy

SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board.

Key Points: 
  • SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board.
  • This highly regarded panel of experts will provide invaluable guidance and insights for the global clinical development of company's innovative product candidates.
  • "As we embark on this exciting journey to advance our differentiated CAR T-cell therapies, I am delighted to welcome our esteemed Clinical Advisory Board members.
  • The formation of this Clinical Advisory Board marks a significant step forward for CARsgen as it continues to pioneer CAR T-cell therapies with the potential to transform cancer treatment.

Gilead Sciences Announces Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Pharmaceutical, AIDS, Oncology, General Health, Health, Infectious Diseases, Hospitals, BIRCH, Food, Pembrolizumab, B-cell lymphoma, Impact of the COVID-19 pandemic on hospitals, EPS, COVID-19, Tax rate, ETR, CAPELLA, Cohort study, Infection, Acute lymphoblastic leukemia, American Association for the Study of Liver Diseases, SARS-CoV-2, Earnings per share, HIV, GAAP, HCV, Safety, Patient, Food and Drug Administration, European Commission, Conference, Obeldesivir, Research, Growth, European, Lung cancer, Total, HDV, PD-L1, Research and development, Incidence, Hepatology, Axicabtagene ciloleucel, Omicron, Liver, Lung, Risk, Science, FTC, Table, Liver disease, HBV, Pharmaceutical industry, Video game, Fine chemical, Security (finance), Virology, Sacituzumab govitecan, Remdesivir

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.
  • During the third quarter of 2023, Gilead generated $1.8 billion in operating cash flow.
  • During the third quarter of 2023, Gilead repaid $2.3 billion of debt, paid dividends of $953 million and repurchased $300 million of common stock.
  • Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.

Gilead and Kite Oncology Present Data Demonstrating Car T-cell Therapy Survival Benefit and Showcasing Latest Advances in Blood Cancer Portfolio at ASH 2023

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical Trials, Survival, CAR, Ageing, Bone marrow, Data, MD, B-cell lymphoma, Doctor of Philosophy, Multimedia, Senior, Abstract, Follicular lymphoma, Patient, BCMA, Lymphoma, Vaccine, Axicabtagene ciloleucel

Additional Yescarta research will focus on new four-year follow-up results from ZUMA-5 evaluating Yescarta in R/R indolent non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma.

Key Points: 
  • Additional Yescarta research will focus on new four-year follow-up results from ZUMA-5 evaluating Yescarta in R/R indolent non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma.
  • Additionally, four-year overall survival data from ZUMA-2 and a ZUMA-18 primary analysis of expanded access in R/R MCL will be highlighted in an oral presentation.
  • New data from the Phase 1 study of CART-dd BCMA will be presented from our multiple myeloma partner, Arcellx.
  • CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy with a novel D-Domain BCMA binder that may improve CAR T-cell binding and killing of multiple myeloma cells.

Gilead and Kite Oncology Present Important New Data Across Multiple Difficult-to-Treat Cancers at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Hospitals, Clinical Trials, Congress, Neoplasm, Multimedia, Cancer, Senior, Doctor of Philosophy, HNSCC, MD, ESMO, B-cell lymphoma, Carcinoma, CAR, Head, TNBC, European Society for Medical Oncology, MBC, Patient, Dana–Farber Cancer Institute, Pharmaceutical industry, Sacituzumab govitecan, Axicabtagene ciloleucel

Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present new data, including three oral presentations, at the European Society for Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present new data, including three oral presentations, at the European Society for Medical Oncology (ESMO) Congress 2023.
  • Kite will also present analyses supporting the use of Yescarta® (axicabtagene ciloleucel) in relapsed/refractory large B-Cell lymphoma (LBCL).
  • View the full release here: https://www.businesswire.com/news/home/20231015111917/en/
    “Our data at ESMO 2023 reflect a broad clinical development program in difficult-to-treat cancers,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology.
  • “We believe our data will help further clinicians’ understanding of when to use Yescarta in these patients and reinforce confidence in CAR T-cell therapies overall.”

Kite’s Car T-cell Therapy Yescarta® Demonstrates High Response Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Retrieved on: 
Monday, September 18, 2023
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical Trials, Progression-free survival, CRS, Drug, Hope, PET, Doctor of Philosophy, PFS, Teaching hospital, B-cell lymphoma, CAR, ASCT, MD, Patient, Standard of care, Frailty, CMR, SVP, Safety, Pharmaceutical industry, Axicabtagene ciloleucel, Nature Medicine

The ALYCANTE study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT.

Key Points: 
  • The ALYCANTE study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT.
  • “Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” said Prof. Roch Houot, Head of Haematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study.
  • The ALYCANTE study included patients deemed ineligible for HDCT/ASCT because of age ≥65 years (88.7%), high hematopoietic cell transplantation-specific comorbidity index score ≥3 (32.3%), and/or prior ASCT (3.2%).
  • “The data generation for Yescarta continues to reaffirm its potential to bring hope to patients suffering from a variety of sub-types of large B-cell lymphoma and follicular lymphoma.”

Appia Bio Expands Leadership Team With Sylvaine Cases, Ph.D. Appointed Chief Business Officer and Alex Babayan, Ph.D. as Vice President, Head of Regulatory Affairs

Retrieved on: 
Wednesday, June 28, 2023
Amgen, Private sector, ACUA, University, University of California, Irvine academics, Cancer research, Cancer, Axicabtagene ciloleucel, Janssen, Head, University of California, Allotransplantation, Research, Stem cell, TCR, Institut Gustave Roussy, Health, Arete, CAR, Metabolism, Patient, Investment, CBO, Biology, LOS, Gladstone Institutes, Therapy, Kite, BLA, IND, Tumor microenvironment, Bangladesh Technical Education Board, Pharmacology, Pharmaceutical industry, Sanofi

LOS ANGELES, June 28, 2023 /PRNewswire/ -- Appia Bio, Inc., a biotechnology company developing allogeneic chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-NKT) cell therapies from hematopoietic stem cells (HSCs) for patients with cancer, today announced the appointments of Sylvaine Cases, Ph.D. as chief business officer (CBO) and Alex Babayan, Ph.D. as vice president, head of regulatory affairs.

Key Points: 
  • "We are delighted to have Sylvaine and Alex join the Appia Bio team.
  • Sylvaine is a thoughtful business executive with deep understanding of our industry from both sides of the table.
  • Alex brings long-term considered insight based on his broad global regulatory affairs experience in cell therapy.
  • Dr. Babayan joins Appia Bio from Instil Bio where he was vice president and head of regulatory affairs.