Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy. “While we continue to make important strides in the treatment of multiple myeloma, unfortunately most patients will relapse at some point, so it is important that physicians have multiple treatment options and regimens for patients,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research &Development, LLC. “The results from the CANDOR study support the potential benefit of this DARZALEX-based combination regimen for patients with multiple myeloma who have relapsed from prior treatment.” Data from the Phase 3 CANDOR study were presented as a late-breaking abstract at the 2019 American Society of Hematology (ASH) Annual Meeting. About the CANDOR Study CANDOR is a randomized, open-label Phase 3 study of DARZALEX® (daratumumab), carfilzomib and dexamethasone (DKd) compared to carfilzomib and...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

Related Links:

Authors: Rombauts A, Abelenda-Alonso G, Cuervo G, Gudiol C, Carratalà J Abstract INTRODUCTION: Despite adequate antibiotic coverage, community-acquired pneumonia (CAP) remains a leading cause of hospitalization and mortality worldwide. It induces both a local pulmonary and a systemic inflammatory response, particularly significant in severe cases. The intensity of the dysregulated host response varies from patient to patient and has a negative impact on survival and other outcomes. AREAS COVERED: This comprehensive review summarizes the pathophysiological aspects of the inflammatory response in CAP, brie...
Source: Expert Review of Anti-Infective Therapy - Category: Infectious Diseases Tags: Expert Rev Anti Infect Ther Source Type: research
Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part BAuthor(s): Yanhua Liu, Yang Li, Shanshan Dong, Lu Han, Ruixin Guo, Yourong Fu, Shenghu Zhang, Jianqiu Chen
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
Publication date: Available online 30 September 2020Source: Journal of Hazardous MaterialsAuthor(s): Anthony Beauvois, Delphine Vantelon, Jacques Jestin, Martine Bouhnik-Le Coz, Charlotte Catrouillet, Valérie Briois, Thomas Bizien, Mélanie Davranche
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
We describe the most highly recommended generic and disease-specific PRO tools in SCD and discuss the challenges of incorporating them in clinical practice. EXPERT OPINION: PRO measures are essential to incorporate into SCD clinical trials either as primary or secondary outcomes. The use of PRO measures in SCD facilitates a patient-centered approach, which is likely to lead to improved outcomes. Significant challenges remain in adapting PRO tools to routine clinical use and in developing countries. PMID: 33034214 [PubMed - as supplied by publisher]
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
Authors: Musio F Abstract INTRODUCTION: Anemia has and will continue to be a central theme in medicine particularly as clinicians are treating a burgeoning population of complex multi-organ system processes. As a result of multiple randomized controlled trials (RCTs), meta-analyses, and societal recommendations overly restrictive paradigms and under-administration of erythropoiesis stimulating agents (ESAs) have likely been followed by clinicians among all specialties. AREAS COVERED: A review of anemia in the context of chronic kidney disease, hematologic malignancies and cancer is presented with focus on the e...
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
Authors: Bergland OU, Søraas CL, Larstorp ACK, Halvorsen LV, Hjørnholm U, Hoffman P, Høieggen A, Fadl Elmula FEM Abstract PURPOSE: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study. MATERIALS AND METHODS: Patients with treatment-resistant hypertension, defined...
Source: Blood Pressure - Category: Hematology Tags: Blood Press Source Type: research
Authors: Zhang W, Xu JZ, Lu XH, Li H, Wang D, Wang JG Abstract PURPOSE: We hypothesise that dietary sodium intake interacts with serum uric acid to influence blood pressure (BP) in children and adolescents. In the present study, we investigated ambulatory BP in relation to hyperuricaemia, dietary sodium intake and their interaction in children and adolescents with hypertension. MATERIALS AND METHODS:  A total of 616 study participants were 10-24 years old and had primary hypertension diagnosed after admission in a specialised inpatient ward. Ambulatory BP monitoring was performed during hospitalisat...
Source: Blood Pressure - Category: Hematology Tags: Blood Press Source Type: research
Publication date: Available online 9 October 2020Source: Mutation Research/Reviews in Mutation ResearchAuthor(s): Klaudia Kulczynska-Figurny, James J. Bieker, Miroslawa Siatecka
Source: Mutation Research Reviews in Mutation Research - Category: Genetics & Stem Cells Source Type: research
Publication date: January 2021Source: Urology Case Reports, Volume 34Author(s): Nina Al-Saadi, Safa Al-Musawi, Yousuf Khan, Daben Dawam
Source: Urology Case Reports - Category: Urology & Nephrology Source Type: research
CONCLUSIONS: Xyloglucan/gelose plus ORS was effective and safe in treating acute diarrhea in children. PMID: 33028102 [PubMed - as supplied by publisher]
Source: Expert Review of Gastroenterology and Hepatology - Category: Gastroenterology Tags: Expert Rev Gastroenterol Hepatol Source Type: research
More News: Allergy & Immunology | Anaphylactic Shock | Anemia | Atrial Fibrillation | Back Pain | Biotechnology | Blood Transusion | Brain | Bronchitis | Calcium | Cancer | Cancer & Oncology | Cancer Vaccines | Cardiology | Cardiovascular | Chronic Leukemia | Chronic Obstructive Pulmonary | Chronic Pain | Clinical Trials | Constipation | Corticosteroid Therapy | Cough | Databases & Libraries | Dexamethasone | Emergency Medicine | Food and Drug Administration (FDA) | Hay Fever | Health Management | Heart | Heart Transplant | Hematology | Hypertension | Infectious Diseases | Influenza | Influenza Vaccine | Insomnia | Internet | Kidney Transplant | Kidney Transplantation | Laboratory Medicine | Laryngeal Cancer | Learning | Legislation | Leukemia | Lymphoma | Myeloma | Neurology | Neuroscience | Oral Cancer | Orthopaedics | Pain | Pain Management | Pharmaceuticals | Pneomococcal Vaccine | Pneumonia | Prednisone | Pulmonary Hypertension | Respiratory Medicine | Revlimid | Science | Stem Cell Therapy | Stem Cells | Study | Thrombocytopenia | Transplant Surgery | Transplants | Universities & Medical Training | Urology & Nephrology | Vaccines | Velcade | Warnings