B-cell lymphoma

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, INN, B-cell lymphoma, Infection, ATC, Pharyngitis, Pneumonia, Pain, CD20, Hypertension, Capsule, International, Bleeding, European, Platelet, Disease, Nose, Neutropenia, Language, Mouth, Cancer, Chronic lymphocytic leukemia, Waldenström macroglobulinemia, Thrombocytopenia, Lymphocytosis, Death, Rituximab, CLL, Neutrophil, DSM-IV codes, European Medicines Agency, BTK, Growth, Select, Patient, Bruise, Time, Anatomy, Bone marrow, IIA, Macroglobulinemia, Rash, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

CARGO Therapeutics Reports Business Updates and Third Quarter 2023 Results

Retrieved on: 
Wednesday, December 13, 2023
Clinical trial, Stanford University, Conference, Survival, Lymphoid leukemia, Relapse, Research, Disease, MD, Doctor of Philosophy, SAN, Society, Therapy, Cancer, ASH, Annual general meeting, Death, Growth, IPO, CD19, Safety, OS, G&A, CD22, B-cell lymphoma, Pharmacology, Pharmaceutical industry

SAN MATEO, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today reported business updates and its financial results for the third quarter ended September 30, 2023.

Key Points: 
  • SAN MATEO, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (Nasdaq: CRGX), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today reported business updates and its financial results for the third quarter ended September 30, 2023.
  • Net loss was $35.5 million, or $47.37 per basic and diluted share, for the quarter ended September 30, 2023.
  • This compares with a net loss of $12.3 million, or $28.38 per basic and diluted share for the quarter ended September 30, 2022.
  • CARGO will participate in the 42nd Annual J.P. Morgan Healthcare Conference, taking place January 8-11, 2024, in San Francisco, California.

Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024

Retrieved on: 
Tuesday, December 12, 2023
ASCT, Regenerative Medicine Advanced Therapy, Food, FDA, CRISPR, Rachel Haurwitz, Reindeer, Doctor of Philosophy, Randomized controlled trial, Orphan drug, B-cell lymphoma, Patient, Fast Track, Pharmaceutical industry

BERKELEY, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today provided an update based on feedback from the U.S. Food and Drug Administration (FDA) following recent communications and a Type B clinical meeting regarding the CB-010 development program. The company has received the FDA’s feedback on a Phase 3 randomized controlled trial for CB-010, an allogeneic anti-CD19 CAR-T cell therapy in development for patients with second-line relapsed or refractory large B cell lymphoma (r/r LBCL). The FDA stated that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.

Key Points: 
  • The FDA stated that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.
  • “As our ongoing ANTLER trial progresses, we look forward to engaging again with the FDA ahead of initiating our planned Phase 3 pivotal trial.
  • In Q2 2024, the company plans to report initial dose expansion data from the ANTLER trial and share the recommended Phase 2 dose (RP2D) for CB-010.
  • Caribou plans to initiate a Phase 3 pivotal trial with this RP2D by year-end 2024.

Viracta Therapeutics Announces Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Tuesday, December 12, 2023
NPC, Food, Nasopharyngeal carcinoma, Post-transplant lymphoproliferative disorder, Drug development, FDA, Disease, Plasmablastic lymphoma, ODD, Therapy, T-cell lymphoma, B-cell lymphoma, EBV, Valganciclovir, Patient, Lymphoma, Pharmaceutical industry

SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Nana-val (nanatinostat in combination with valganciclovir), the company's all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, for the treatment of nasopharyngeal carcinoma (NPC). This represents the first ODD granted for Nana-val in Epstein-Barr virus-positive (EBV+) solid tumors and outside of EBV-associated lymphomas. The FDA previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and EBV+ diffuse large B-cell lymphoma, not otherwise specified.

Key Points: 
  • This represents the first ODD granted for Nana-val in Epstein-Barr virus-positive (EBV+) solid tumors and outside of EBV-associated lymphomas.
  • The FDA previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and EBV+ diffuse large B-cell lymphoma, not otherwise specified.
  • "This orphan drug designation highlights the urgent need for new targeted treatment options for patients with rare diseases such as nasopharyngeal carcinoma, which is highly associated with EBV," said Mark Rothera, President and Chief Executive Officer of Viracta.
  • With sites open and enrolling the sixth dose cohort of the study, we are on track to expand into the Phase 2 portion in 2024.

Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes

Retrieved on: 
Monday, December 11, 2023
Telephone, Regeneron Pharmaceuticals, Quality of life, Food, Quality of life (healthcare), Treatment, Fever, DLBCL, EMA, FDA, CD20, Cytokine release syndrome, Dor, Anemia, Neutropenia, Pros, Orphan, Society, Research, B-cell lymphoma, ASH, Neuropsychological test, ICR, COVID-19, European Medicines Agency, ID, Fast track (FDA), University of Nantes, CRS, Webcast, Patient, Safety, Medicine, PFS, Pharmaceutical industry

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data for odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) from a pivotal Phase 2 trial (ELM-2). These data – which include updated efficacy, safety and patient-reported outcomes (PROs) – were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
  • “As clinicians, our focus must remain patients’ wellbeing, along with favorable outcomes.
  • For odronextamab, it is particularly encouraging to see the unprecedented clinical results complemented by patient-reported outcomes that show quality of life and functional measures are maintained overall.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

Marker Therapeutics Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse

Retrieved on: 
Monday, December 11, 2023
Risk, Principal, DLBCL, FDA, City, Therapy, Press release, B-cell lymphoma, Neurotoxicity, Mutagenesis, Chong, Patient, Lymphoma, Bone marrow, Food and Drug Administration, APOLLO, Pharmaceutical industry

The patient had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.

Key Points: 
  • The patient had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.
  • Marker reports today that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment.
  • “Relapse rates following CAR T cell therapy are high,” said Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics.
  • “The ongoing complete response observed after MT-601 infusion in a CAR relapsed patient with lymphoma suggests superior durability of our therapy over CAR T cells in this patient.

Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes

Retrieved on: 
Sunday, December 10, 2023
DLBCL, IPI, Cytokine release syndrome, CD20, Anemia, International, Dor, Neutropenia, City, Society, B-cell lymphoma, ASH, ICR, CRS, Patient, Phase II, Regeneron Pharmaceuticals

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The data from the pivotal Phase 2 trial (ELM-2) and Phase 1 trial (ELM-1) were shared in several presentations – including two orals – at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
  • “Diffuse large B-cell lymphoma has a high risk of relapse, which is why it is so critical to demonstrate continued disease control over the long term.
  • “The primary analysis from the pivotal trial of odronextamab demonstrated impressive response rates, including in certain high-risk subgroups.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

Allogene Therapeutics Presents Comprehensive Safety Data of Proprietary Lymphodepletion Agent ALLO-647 at the 65th Annual Meeting of the American Society of Hematology

Retrieved on: 
Saturday, December 9, 2023
Research and development, Incidence, Anemia, Kite Pharma, SAN, Society, Therapy, Follicular lymphoma, Cancer, Thrombocytopenia, ASH, B-cell lymphoma, Patient, Development, Cytopenia, FC, Vaccine

The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.

Key Points: 
  • The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.
  • Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs.
  • Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients.
  • Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy.2-4

U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data

Retrieved on: 
Thursday, December 21, 2023
Oncology, FDA, Health, Hospitals, Pharmaceutical, Biotechnology, ASCT, Survival analysis, Palliative care, Food, Survival, Risk, Arm, HDT, MD, Doctor of Philosophy, B-cell lymphoma, Standard of care, Medicine, Death, European Medicines Agency, Medication package insert, Patient, OS, SOC, Senior, Pharmaceutical industry

The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS.

Key Points: 
  • The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS.
  • The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm.
  • “Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard of care treatment.
  • *Treatment of curative intent is a line of treatment administered with the goal of achieving a durable complete response/ remission.

Bionano Announces Presentation of OGM Utility Across Key Research Applications at the Association for Molecular Pathology Annual Meeting

Retrieved on: 
Tuesday, November 14, 2023
CNS, Research, Bone marrow, SAN, OGM, University, Hospital, Scalability, B-cell lymphoma, Expo Hall, Genomics, Second Level Address Translation, CD5, Laboratory, Neoplasm, Crocker, Ravindra and Smita Kolhe, Workflow, DSM-IV codes, SVS, Convention center, Greater Columbus Convention Center, Cancer, Mapping, Central nervous system, MD Anderson Cancer Center, AMP, Medical device, Vaccine, DRS, Adult, Brigham

AMP’s annual meeting brings together industry, medical, and academic professionals to discuss advances in molecular diagnostics.

Key Points: 
  • AMP’s annual meeting brings together industry, medical, and academic professionals to discuss advances in molecular diagnostics.
  • The presenters will share data on OGM’s performance in this research application as compared to traditional cytogenetic methods of analysis, including microarrays.
  • Ryall, Dubuc and Crocker presenting clinical research data generated using OGM across different types of hematological malignancies.
  • In addition, 19 posters featuring results from OGM applications in cytogenetic research will be presented at the conference.