PMBCL

Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Date of authorisation: 23/08/2018, Revision: 13, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, INN, Risk, Fever, Diffusion, DLBCL, ATC, Bone marrow, Pain, Cytokine release syndrome, International, Encephalopathy, Headache, Disease, Language, Blood, Hospital, Cancer, B-cell lymphoma, Myenteric plexus, Death, European Medicines Agency, Infection, PMBCL, Select, Cell, CD19, Time, Anatomy, Somnolence, Vomiting, IIA, Follicular lymphoma, Medical device

Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Date of authorisation: 23/08/2018, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Date of authorisation: 23/08/2018, Revision: 13, Status: Authorised

Industry Report Explores YESCARTA Drug Prospects and Market Forecast for DLBCL Treatment up to 2032 - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Pharmaceutical, Research, Diffuse large B-cell lymphoma, PMBCL, Clinical trial, Patient, SWOT, EU4, Dietary supplement, Risk management, Medical imaging, Pharmaceutical industry, DLBCL

The "YESCARTA Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "YESCARTA Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • Crucial for industry stakeholders, the report offers future market assessments alongside comprehensive SWOT analysis, the analyst viewpoint on YESCARTA, and a competitive overview of market rivals.
  • YESCARTA (axicabtagene ciloleucel) represents a significant advancement in DLBCL treatment as a CD19-directed CAR-T cell immunotherapy.
  • How will evolving market trends and the entry of new therapies impact the forecasted market scenario for DLBCL treatment?

EPKINLY™ (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain Types of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Retrieved on: 
Monday, September 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, PMBCL, Neutropenia, DLBCL, Ministry of Health, Labour and Welfare, Prognosis, Appetite, Doctor of Philosophy, B-cell lymphoma, Rash, ORR, Lymphocytopenia, Cytokine release syndrome, MD, AbbVie, Patient, Thrombocytopenia, Safety, Pharmaceutical industry, Genmab

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Key Points: 
  • Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.
  • Of 157 patients treated with EPKINLY, 130 (82.8 percent) experienced treatment related side effects.
  • The most common side effects (>15 percent) included cytokine release syndrome (49.7 percent), injection site reactions (19.7 percent), and neutropenia (17.8 percent).
  • Of 36 patients treated with EPKINLY, 36 (100 percent) experienced treatment related side effects.

Caribou Biosciences Reports Positive Clinical Data from Dose Escalation of CB-010 ANTLER Phase 1 Trial in r/r B-NHL

Retrieved on: 
Thursday, July 13, 2023
PMBCL, Rachel Haurwitz, CRISPR, University, B-cell lymphoma, PD, Follicular lymphoma, Reindeer, DLBCL, DLT, MD Anderson Cancer Center, Doctor of Philosophy, MD, Patient, Mantle cell lymphoma, CR, MCL, Infrared spectroscopy correlation table, PD-1, FDA, ORR, Safety, Bookkeeping, Pharmaceutical industry, Vaccine

-- Conference call and webcast scheduled for today at 4:30 pm ET --

Key Points: 
  • In ANTLER dose escalation, three dose levels of CB-010 were evaluated (40x106, 80x106, and 120x106 CAR-T cells) in patients with multiple subtypes of aggressive r/r B-NHL.
  • Based on these positive data, Caribou is enrolling second-line patients with LBCL in the ongoing dose expansion portion of the ANTLER clinical trial.
  • Caribou plans to report initial dose expansion data from the ongoing ANTLER trial in H1 2024.
  • “I am excited to see the initial and durable response rates for patients following a single dose of CB-010 in the ANTLER Phase 1 clinical trial.

Genmab Showcases Data From Comprehensive Epcoritamab Development Program in Patients Across B-Cell Lymphomas at European Hematology Association (EHA) Annual Meeting 2023

Retrieved on: 
Friday, June 9, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Neutropenia, PMBCL, Primary mediastinal B-cell lymphoma, Diarrhea, NCT, CRS, ABBV, OS, Cancer, Doctor of Philosophy, B-cell lymphoma, ASCO, Congress, Hematological Cancer Research Investment and Education Act, R2, American Society of Clinical Oncology, HIV disease progression rates, MD, AbbVie, Patient, Cytokine release syndrome, EHA, CR, Nausea, CMR, G3, Fever, Abstract, Society, NYSE, ORR, University of Barcelona, Safety, Fatigue, Disease, Pharmaceutical industry, DLBCL, Genmab

These preliminary results will be presented today during an oral presentation at the 2023 European Hematology Association (EHA) Congress, being held in Frankfurt, Germany and virtually, June 8-11, 2023 ( Abstract #S222 ).

Key Points: 
  • These preliminary results will be presented today during an oral presentation at the 2023 European Hematology Association (EHA) Congress, being held in Frankfurt, Germany and virtually, June 8-11, 2023 ( Abstract #S222 ).
  • Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies' oncology collaboration.
  • Results from this study were also presented at this year’s American Society of Clinical Oncology (ASCO) Meeting on June 6, 2023.
  • The median overall survival (OS) was 18.5 months for LBCL patients and 19.4 months for DLBCL patients.

Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Retrieved on: 
Wednesday, May 3, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, PMBCL, Bristol Myers Squibb, Civil service commission, Progression-free survival, Hematology, Non-Hodgkin lymphoma, HSCT, Haematopoietic system, PFS, B-cell lymphoma, BMY, CAR, Patient, Cell, EFS, EC, NYSE, European Commission, Salvage therapy, Disease, Pharmaceutical industry, EU, DLBCL

“With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb.

Key Points: 
  • “With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb.
  • With Breyanzi, the majority (73.9%) of patients achieved a CR compared to less than half (43.5%) of those who were treated with standard therapy.
  • Any-grade CRS was reported in less than half of patients (48.9%), with Grade 3 CRS reported in 1% of patients.
  • Any-grade neurologic events were reported in 10.9% of patients treated with Breyanzi, with Grade 3 neurologic events reported in 4.3% of patients.

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Retrieved on: 
Friday, March 31, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, PMBCL, Bristol Myers Squibb, Civil service commission, DLBCL, European Medicines Agency, Committee for Medicinal Products for Human Use, B-cell lymphoma, BMY, Committee, EMA, Patient, European, NYSE, European Commission, CHMP, Vaccine, Pharmaceutical industry, EU

“This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb.

Key Points: 
  • “This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb.
  • The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.
  • *
    Bristol Myers Squibb thanks the patients and investigators involved in the TRANSFORM study.
  • *Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy

Retrieved on: 
Tuesday, November 29, 2022
CR, PMBCL, B-cell lymphoma, PD-1, Food, RNA, DNA, Rachel Haurwitz, Risk, Safety, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, EHA, White Light Rock & Roll Review, Accelerated approval (FDA), Annual report, CRISPR/Cpf1, TRAC, Orphan drug, European Hematology Association, Fast Track, Genome, CAR, Lymphatic system, Security (finance), Reindeer, Phenotype, Research, Congress, Clinical trial, Priority, CRISPR, DLBCL, FDA, Vaccine, Pharmaceutical industry, Sewing

BERKELEY, CA, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B cell lymphoma (LBCL) and Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, is being evaluated in the company’s ongoing ANTLER Phase 1 clinical trial in patients with r/r B-NHL, which can enroll three LBCL subtypes: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), and high-grade B cell lymphoma (HGBL). CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion.

Key Points: 
  • We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies.
  • Encouraging safety data and antitumor activity for CB-010 at dose level 1 (40x106 CAR-T cells) have been reported from the ANTLER trial .
  • CB-010 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations.
  • Caribou Biosciences and the Caribou logo are registered trademarks of Caribou Biosciences, Inc.