U.S. FDA Approves IMBRUVICA ® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease
August 24, 2022 (HORSHAM, PA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. This milestone marks the first pediatric indication for IMBRUVICA® and the introduction of a new oral suspension formulation for patients ages one to less than 12. IMBRUVICA® is now the first FDA-approved therapy for these younger patients who previously had no approv...
Source: Johnson and Johnson - August 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
European Commission Approves IMBRUVICA ® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, 4 August 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA® (ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). The approval is based on the pivotal Phase 3 GLOW study that demonstrated superior progression-free survival (PFS) in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O), and the FD cohort of the Phase 2 CAPTIVATE study, which showed deep ...
Source: Johnson and Johnson - August 4, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news
Heed Cardiac Risk of Bruton Tyrosine Kinase Inhibitors for CLL Heed Cardiac Risk of Bruton Tyrosine Kinase Inhibitors for CLL
Experts are urging caution regarding the cardiac risks of Bruton tyrosine kinase inhibitors in treating chronic lymphocytic leukemia.MDedge News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 22, 2022 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follicular lymphoma) andT...
Source: Roche Investor Update - July 21, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Basel, 21 July 2022Group sales up 5%1 at constant exchange rates (CER) and 5% in Swiss francsPharmaceuticals Divisionsales increase 3%; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down furtherDiagnostics Divisionsales grow 11%; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the yearIFRSnet income increases by 12% (12% in Swiss francs), whilecore earnings per share are up 11%Highlights in the second quarter:EU approvals ofPolivy (first-line treatment for aggressive form of blood cancer),Lunsumio (follic...
Source: Roche Media News - July 21, 2022 Category: Pharmaceuticals Source Type: news
Johnson & Johnson Reports Q2 2022 Results
New Brunswick, N.J. (July 19, 2022) – Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter 2022. “Our solid second quarter results across Johnson & Johnson reflect the strength and resilience of our Company’s market leadership in the midst of macroeconomic challenges,” said Joaquin Duato, Chief Executive Officer. “I am continually energized by the focus and passion of my Johnson & Johnson colleagues and their dedication toward delivering transformative healthcare solutions to patients and consumers around the world.”OVERALL FINANCIAL RESULTS
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Source: Johnson and Johnson - July 19, 2022 Category: Pharmaceuticals Tags: Financial Source Type: news
Zanubrutinib Wins in First-Line CLL for Older Patients
(MedPage Today) -- Zanubrutinib (Brukinsa) was superior to chemoimmunotherapy as frontline treatment for older or comorbid patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the phase III SEQUOIA study showed.... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - July 9, 2022 Category: Hematology Source Type: news
FDA Warns of Increased Mortality Risk With Duvelisib
(MedPage Today) -- The FDA on Thursday warned about the possible increased risk of death or serious side effects with duvelisib (Copiktra) in adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
Long-term results from... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - July 1, 2022 Category: Hematology Source Type: news
Janssen Receives Positive CHMP Opinion for IMBRUVICA ® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
BEERSE, BELGIUM, June 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology.[1] This provides the opportunity...
Source: Johnson and Johnson - June 24, 2022 Category: Pharmaceuticals Source Type: news
Blood cancer specialist blends curiosity and persistence in studying chronic lymphocytic leukemia
The life-or-death mystery confounded Dr. Jennifer Woyach, whose team faced a puzzling setback involving a breakthrough drug that had stopped working in some patients with chronic lymphocytic leukemia (CLL).
That drug, called ibrutinib, had been developed largely through basic and clinical research by physicians and scientists at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), and it… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - June 21, 2022 Category: Health Management Authors: The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute Source Type: news
Blood cancer specialist blends curiosity and persistence in studying chronic lymphocytic leukemia
The life-or-death mystery confounded Dr. Jennifer Woyach, whose team faced a puzzling setback involving a breakthrough drug that had stopped working in some patients with chronic lymphocytic leukemia (CLL).
That drug, called ibrutinib, had been developed largely through basic and clinical research by physicians and scientists at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), and it… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 21, 2022 Category: American Health Authors: The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute Source Type: news
New IMBRUVICA ® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
June 10, 2022 (VIENNA) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new and updated results from the Phase 2 CAPTIVATE study evaluating IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) as a potential fixed-duration (FD) treatment in adult patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Updated data from the FD cohort with three years of follow-up shows that I+V continues to demonstrate deep and durable responses and clinically meaningful progression-free survival (PFS) and overall survival (OS) in the first-line tre...
Source: Johnson and Johnson - June 10, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting
Long-term data at the European Hematology Association (EHA) 2022 congress expands understanding of the impact of Roche medicines in early-stage blood cancers with the goal of providing patients with robust and durable outcomes from their first treatmentUpdated data from phase III CLL14 study of Venclexta ®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukaemia remained in remission five years after starting treatment[1]Final analysis of phase III GALLIUM study showed meaningful improvement in progression-free survival was main...
Source: Roche Investor Update - June 10, 2022 Category: Pharmaceuticals Source Type: news
Roche announces positive data from broad blood cancer portfolio at European Hematology Association Annual Meeting
Long-term data at the European Hematology Association (EHA) 2022 congress expands understanding of the impact of Roche medicines in early-stage blood cancers with the goal of providing patients with robust and durable outcomes from their first treatmentUpdated data from phase III CLL14 study of Venclexta ®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukaemia remained in remission five years after starting treatment[1]Final analysis of phase III GALLIUM study showed meaningful improvement in progression-free survival was main...
Source: Roche Media News - June 10, 2022 Category: Pharmaceuticals Source Type: news
Phase 3 SHINE Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma
This study is one of the largest clinical trials ever conducted in first-line MCL and the first for a Bruton’s tyrosine kinase inhibitor (BTKi).[1] The data are being presented in an oral session and featured in a press briefing during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine today. The data will also be presented as an oral presentation at the 2022 European Hematology Association (EHA) Annual Congress. MCL is a type of aggressive, rare non-Hodgkin lymphoma (NHL) that is incurable and difficult to treat.[2] It commonly affects people o...
Source: Johnson and Johnson - June 3, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news
