Chlorambucil

Mallinckrodt Presents Latest Health Economics Data on Acthar® Gel (Repository Corticotropin Injection) at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023

Retrieved on: 
Thursday, October 26, 2023
Nexus, Patient, FDA, Academy of Managed Care Pharmacy, Research, Standard of care, Cyclophosphamide, Food, Outcomes research, ClinicoEconomics and Outcomes Research, Treatment, NS, Adrenocorticotropic hormone (medication), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, D20, QALY, Poster, Nephrotic syndrome, Congenital nephrotic syndrome, Adrenocorticotropic hormone, Sarcoidosis, Chlorambucil, Rituximab, Symphony, ICER, SOC, Calcineurin, AMCP, Azathioprine, Diagnosis, Proteinuria, Pharmaceutical industry, Medical imaging, Mallinckrodt

DUBLIN, Oct. 26, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, recently shared findings from Mallinckrodt's latest health economics outcomes research on Acthar® Gel (repository corticotropin injection) for patients with advanced symptomatic sarcoidosis and nephrotic syndrome (NS)1,2 at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 in Orlando, FL October 16-19, 2023.

Key Points: 
  • Patients were monitored at the end of a three-month cycle for a partial or complete response.
  • The full data manuscript from this study was published in ClinicoEconomics and Outcomes Research on October 17, 2023.
  • "We are pleased to have shared our latest health economics research on Acthar Gel.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to Acthar.

AbbVie's VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) Patients

Retrieved on: 
Friday, June 9, 2023
CLL, Neutropenia, Rituximab, Obinutuzumab, Febrile neutropenia, Ars, Royal Melbourne Hospital, European Hematology Association, Diarrhea, German, Grade 3, ABBV, Roche, Aes, Bone marrow, OS, Cytokine, PFS, MRD, Congress, Chlorambucil, AbbVie, Patient, Anemia, Confidence interval, EHA, Hematology, Nausea, Press, Upper respiratory tract infection, Safety, Thrombocytopenia, NYSE, Venetoclax, Pneumonia, Fatigue, Pharmaceutical industry, Fine chemical, Genentech

The results are being presented during oral sessions at the European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.

Key Points: 
  • The results are being presented during oral sessions at the European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.
  • "These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off treatment."
  • New six-year follow-up results from the Phase 3 CLL14 study showcase updated outcomes in previously untreated patients with CLL and co-existing conditions.
  • "These results confirm the treatment benefits of fixed-duration venetoclax and obinutuzumab for previously untreated CLL patients with co-existing conditions."

Polycythemia Vera Epidemiology Forecast 2023-2032: Cases Expected to Increase Across Regions and Genders - ResearchAndMarkets.com

Retrieved on: 
Monday, March 20, 2023
Health, Biotechnology, Haematopoiesis, EU4, Ruxolitinib, Prevalence, Hydroxycarbamide, Epidemiology, PMF, Acute leukemia, Primary myelofibrosis, Risk, PV, Chlorambucil, Bone marrow failure, Polycythemia, Patient, Hematology, Blood, Splenomegaly, Busulfan, JAK2, United Kingdom, Diagnosis, HSC, Myeloproliferative neoplasm, FDA, Leukemia, Phenotype, MPN, Disease, Vaccine, Renewable energy

The "Polycythemia Vera - Epidemiology Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Polycythemia Vera - Epidemiology Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • The prevalence is projected to increase during the forecasted period
    In the United States, there were approximately 69,000 males and about 38,000 females affected with PV in 2022.
  • This 'Polycythemia Vera (PV)- Epidemiology Forecast-2032' report delivers an in-depth understanding of the disease, historical and forecasted epidemiology in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.
  • Polycythemia Vera is a rare blood disease in which the body makes excessive red blood cells.

European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

Retrieved on: 
Thursday, August 4, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Janssen Pharmaceuticals, EC, Johnson & Johnson, Mantle cell lymphoma, Lymphatic system, GLOW, Lymphocytosis, Bone marrow, Patient, University of Amsterdam, Progression-free survival, European Commission, Disease, Time-invariant system, EMEA, Venetoclax, Blood, PFS, Chlorambucil, University, Royal commission, FD, Pharmaceutical industry, Bachelor of Medicine, Bachelor of Surgery, CLL

Over the past 11 years, the efficacy and safety profile of ibrutinib has been established in clinical trials and real-world settings.

Key Points: 
  • Over the past 11 years, the efficacy and safety profile of ibrutinib has been established in clinical trials and real-world settings.
  • This approval reinforces our relentless ambition to advance and optimise treatment regimens, including this all-oral, once-daily, fixed-duration combination of ibrutinib-venetoclax, delivering deep and durable remissions for patients with previously untreated CLL.
  • This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding IMBRUVICA (ibrutinib).
  • Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Ann Oncol.

Waldenstrom Macroglobulinemia - Market Insight, Epidemiology and Market Forecast - 2030 - ResearchAndMarkets.com

Retrieved on: 
Friday, December 17, 2021
Health, Pharmaceutical, Peripheral neuropathy, Chlorambucil, II, NHL, HIV disease progression rates, Clinical trial, Algorithm, Diagnosis, Awareness, Mutation, Lymph, Incidence, III, Table, Immunoglobulin M, Acquisition, Non-Hodgkin lymphoma, B-cell lymphoma, Cytopenia, Alkylation, Bortezomib, Patient, Disease, Cyclophosphamide, Tissue, Therapy, Health insurance coverage in the United States, Cladribine, Bone marrow, Plasmapheresis, BTK, Lymphatic system, LPL, Physiology, Comprehension, News, Technology, Pharmaceutical industry, Medical device, Dentistry, Management, Agriculture, Renewable energy, Health insurance, Macroglobulinemia, Epidemiology, EU, Waldenström's macroglobulinemia, Rituximab

This 'Waldenstrom Macroglobulinemia (WM) - Market Insights, Epidemiology, and Market Forecast - 2030' report delivers an in-depth understanding of the Waldenstrom Macroglobulinemia, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

Key Points: 
  • This 'Waldenstrom Macroglobulinemia (WM) - Market Insights, Epidemiology, and Market Forecast - 2030' report delivers an in-depth understanding of the Waldenstrom Macroglobulinemia, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
  • The Waldenstrom Macroglobulinemia market report thoroughly understands Waldenstrom Macroglobulinemia symptoms by including disease definition, symptoms, causes, physiology, and diagnosis.
  • It also provides Waldenstrom Macroglobulinemia treatment algorithms and treatment guidelines for Waldenstrom Macroglobulinemia symptoms in the US, Europe, and Japan.
  • The disease epidemiology covered in the report provides historical as well as forecasted Waldenstrom Macroglobulinemia (WM) symptoms epidemiology segmented as the Incidence of Waldenstrom Macroglobulinemia, Gender-specific cases of Waldenstrom Macroglobulinemia, Age-specific Cases of Waldenstrom Macroglobulinemia, and Genetic Mutations in Waldenstrom Macroglobulinemia.

Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients

Retrieved on: 
Sunday, December 6, 2020
RTT, Chlorambucil, Organochlorides, Chemical substances, Chemistry, Physical sciences

In RESONATE-2 (NCT01722487), patients aged 65 years without del(17p) were randomized to single-agent IMBRUVICA or chlorambucil.

Key Points: 
  • In RESONATE-2 (NCT01722487), patients aged 65 years without del(17p) were randomized to single-agent IMBRUVICA or chlorambucil.
  • In iLLUMINATE (NCT02264574), patients aged 65 years, or
  • The integrated analysis included 498 patients treated with first-line IMBRUVICA -based or chlorambucil-based therapy (n=249 each) with a median follow-up of 49.1 months.
  • Eighty-nine patients with TP53 aberrations receiving first-line IMBRUVICA treatment were included in this pooled analysis.

Pivotal Phase III CLL14 Results for Venclexta in Combination with Gazyva for Chronic Lymphocytic Leukemia Presented at ASCO 2019 and Published in the New England Journal of Medicine

Retrieved on: 
Tuesday, June 4, 2019
Health, Biotechnology, Clinical trials, Oncology, Pharmaceutical, RTT, Breakthrough therapy, Hoffmann-La Roche, Genentech, Obinutuzumab, CLL, Chlorambucil, Leukemia, Asco, Drugs, Health, Chemical substances

The results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).

Key Points: 
  • The results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).
  • These data were presented at the 2019 ASCO Annual Meeting on Tuesday, June 4, 2019, at 10:09-10:21 CST (Abstract #7502), and simultaneously published in NEJM.
  • CLL14 (NCT02242942) is a randomized Phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.
  • In the United States, it is estimated that more than 20,000 new cases of CLL will be diagnosed in 2019.

Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions

Retrieved on: 
Thursday, March 7, 2019
Health, Biotechnology, Pharmaceutical, RTT, Breakthrough therapy, Hoffmann-La Roche, Cancer, Health, Chronic lymphocytic leukemia, Obinutuzumab, CD20, Drugs, Leukemia, Chlorambucil, CLL

Breakthrough Therapy Designation was granted based on results of the randomized Phase III CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions.

Key Points: 
  • Breakthrough Therapy Designation was granted based on results of the randomized Phase III CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions.
  • CLL14 (NCT02242942) is a randomized Phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.
  • Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia.
  • Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells.

U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia

Retrieved on: 
Monday, January 28, 2019
RTT, Drugs, Breakthrough therapy, Chemical compounds, Organic compounds, Hoffmann-La Roche, Obinutuzumab, Ibrutinib, Rituximab, Chronic lymphocytic leukemia, Leukemia, Chlorambucil

The approval expands the label for IMBRUVICA in frontline CLL/SLL beyond its use as a monotherapy to include combination use with obinutuzumab.

Key Points: 
  • The approval expands the label for IMBRUVICA in frontline CLL/SLL beyond its use as a monotherapy to include combination use with obinutuzumab.
  • "In just a few years, IMBRUVICA has become an important treatment for chronic lymphocytic leukemia.
  • The IRC-evaluated overall response rate was 89 percent in the IMBRUVICA plus obinutuzumab arm versus 73 percent in the chlorambucil plus obinutuzumab arm.
  • When administering IMBRUVICA in combination with rituximab or obinutuzumab, doctors should consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.

IMBRUVICA® (ibrutinib) Plus Obinutuzumab Showed Significant Improvement in Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Retrieved on: 
Monday, December 3, 2018
Breakthrough therapy, Chemistry, Hoffmann-La Roche, Obinutuzumab, RTT, Health, Organic chemistry, Survival rate, Ibrutinib, ARM architecture, Chlorambucil

Overall survival (OS) rates at 31 months were 86 percent for the IMBRUVICA plus obinutuzumab arm compared to 85 percent for the chlorambucil plus obinutuzumab arm.

Key Points: 
  • Overall survival (OS) rates at 31 months were 86 percent for the IMBRUVICA plus obinutuzumab arm compared to 85 percent for the chlorambucil plus obinutuzumab arm.
  • No patients discontinued obinutuzumab due to IRRs in the IMBRUVICA plus obinutuzumab arm compared to the chlorambucil plus obinutuzumab arm (6 percent).
  • AEs led to the discontinuation of obinutuzumab in the IMBRUVICA plus obinutuzumab arm (9 percent) and chlorambucil plus obinutuzumab arm (13 percent).
  • With about three years of follow-up, 70 percent of patients in the IMBRUVICA plus obinutuzumab arm remain on IMBRUVICA monotherapy.