Lymphocytosis

U.S. FDA Approves Bristol Myers Squibb’s Breyanzi® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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Friday, March 15, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, SLL, BMY, B-cell lymphoma, Chronic lymphocytic leukemia, CLL, Bone marrow, Caregiver, Patient, Lymphocytosis, City, CRS, Commercial, Bristol Myers Squibb, BTK, MRD, Cytokine release syndrome, Division, Drug resistance, Multimedia, Blood, Associate professor, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
  • “For years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success.
  • After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses.

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.

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, February 15, 2024
Fast Track, BTK, MCL, Research, B-cell lymphoma, ASH, NHL, Inflammation, FDA, CLL, Calendar, Mantle cell lymphoma, Manuscript, Medicinal chemistry, Lymphocytosis, BCL2, Lymphoma, Society, Chronic lymphocytic leukemia, Therapy, Pharmacology, Accelerated approval (FDA), Rheumatoid arthritis, Lymphoid leukemia, Paclitaxel, Non-Hodgkin lymphoma, Patient, Journal, Clinical trial, Science, IND, Publication, Trial of the century, DLBCL, Cancer, Priority review, Pharmaceutical industry

NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).

Key Points: 
  • NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).
  • NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies.
  • During the year ended November 30, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $12.5 million and $7.0 million, respectively.
  • Cash, cash equivalents and marketable securities was $295.3 million as of November 30, 2023, compared to $268.7 million as of August 31, 2023.

Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Retrieved on: 
Tuesday, January 30, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Follicular lymphoma, Mantle cell lymphoma, Bristol Myers Squibb, ICML, MCL, Clinical trial, Lymphocytosis, Patient, New Drug Application, Shanda, Lymphoma, FDA, BMY, Priority review, Food, Society, MHLW, PDUFA, ASH, NHL, Chronic lymphocytic leukemia, Conference, Pharmaceutical industry

In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).

Key Points: 
  • In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).
  • The FDA has granted both applications Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 23, 2024 for Breyanzi in relapsed or refractory FL and May 31, 2024 for Breyanzi in relapsed or refractory MCL.
  • Japan's MHLW has also accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.
  • In both studies, Breyanzi demonstrated a consistent safety profile with no new safety signals reported.

Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory CLL and SLL

Retrieved on: 
Tuesday, January 16, 2024
Patient, Lymphocytosis, Șaeș, Accelerated approval (FDA), Therapy, CLL, Hypertension, SAN, Atrial fibrillation, Society, Cancer, BTK, Food, BCL2, Safety, Inflammation, Fast Track, Priority review, FDA, ASH, Chronic lymphocytic leukemia, Infrared spectroscopy correlation table, Pharmaceutical industry

“This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes.

Key Points: 
  • “This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes.
  • To qualify, available clinical and non-clinical data need to demonstrate a therapeutic candidate’s potential to address an unmet medical need.
  • A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
  • Additional data with higher dose levels and longer treatment duration are expected in 2024.

Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline

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Friday, January 5, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, LSD1, Lung cancer, Science, Lymphocytosis, Bone marrow, Research, Malignancy, Orion, Chronic lymphocytic leukemia, CLL, Merck & Co., BTK, Cancer, Patient, SLL, MRK, ADC, Therapy, NSCLC, CYP11A1, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors.
  • Global Phase 3 studies have been initiated and are actively enrolling for the following investigational candidates:
    Bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, being evaluated for the treatment of certain patients with essential thrombocythemia (ET);
    Nemtabrutinib, an investigational oral, reversible, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, being evaluated for the treatment of certain patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL);
    MK-2870, an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, which is being evaluated for certain patients with non-small cell lung cancer (NSCLC) and certain patients with previously treated endometrial carcinoma;
    and MK-5684, an investigational CYP11A1 inhibitor being developed in collaboration with Orion, which is being evaluated for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
  • “These Phase 3 trial initiations for four of our investigational candidates represent a critical step forward in our efforts to advance potential treatment options for people with solid tumors and hematologic neoplasms and malignancies,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
  • “We have a proud legacy of turning breakthrough science into medicines that save and improve lives around the world, and we are dedicated to continuing research to expand our broad portfolio of oncology therapeutics to continue to address unmet needs in cancer care.”

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

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Thursday, January 4, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Overview, B cell, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Rixathon, rituximab, Date of authorisation: 15/06/2017, Revision: 13, Status: Authorised

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
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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

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, BAL, PV, INN, Risk, MPA, Shivering, DLBCL, Pemphigus, CD20, BLL, PML, Pemphigus vulgaris, Cancer, Inflammation, Infection, Anatomy, IIA, Skin, Chills, Fever, ATC, Bone marrow, GPA, Nose, Ageing, Allergy, Glucocorticoid, CLL, NHL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, Lymphocytosis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Riximyo, rituximab, Date of authorisation: 15/06/2017, Revision: 15, Status: Authorised

NovalGen presents NVG-111 clinical data in hematological malignancies in an oral session and preclinical data for next-generation AR T cell engager NVG-222 at the 65th American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Therapeutic index, Drug resistance, Immunotherapy, Survival, CMR, Malignancy, Mantle cell lymphoma, Half-life, Health, Society, Bone marrow, Hematology, Lymphocytosis, CLL, Toxicity, Patient, Therapy, Pharmacology, Flow cytometry, MCL, Vaccine

LONDON, Dec. 10, 2023 (GLOBE NEWSWIRE) -- NovalGen Ltd (“NovalGen”), a pioneering clinical stage immunology company, shared promising findings from the NVG-111-101, a First in Human, Phase I clinical study (NCT04763083), in an oral presentation at the 65th American Society of Hematology Annual meeting, in San Diego, USA. The study showcased positive responses in 58% of evaluable patients with relapsed refractory chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL) across both combination and monotherapy regimens, durable to 24 months.

Key Points: 
  • Noteworthy outcomes include a remarkable achievement of MRD4 negativity in peripheral blood, determined by flow cytometry, in 30% of CLL participants.
  • Furthermore, a complete metabolic response (CMR) by Lugano criteria was observed in one of two mantle cell lymphoma participants.
  • Such outcomes are particularly significant in diseases characterized by poor T cell function and are associated with improved progression free survival and overall survival.
  • The enhanced safety profile of this novel molecule allows for higher, more efficacious dosing, potentially leading to improved patient outcomes.