FDA grants priority review to Roche ’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
If approved,glofitamab would be the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody approved to treat the most aggressive type of non-Hodgkin lymphomaResults from the pivotal phase I/II NP30179 study showedglofitamab induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete responseGlofitamab is part of Roche ’s industry-leading portfolio of T-cell engaging bispecific antibodies, which also includes the newly FDA-approved first-in-classLunsumio to treat follicular lymphomaBasel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announc...
Source: Roche Media News - January 6, 2023 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma
The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CR...
Source: Roche Media News - December 23, 2022 Category: Pharmaceuticals Source Type: news
FDA approves Roche ’s Actemra for the treatment of COVID-19 in hospitalised adults
Actemra is the first FDA-approved monoclonal antibody to treat COVID-19Since the beginning of the pandemic, more than one million peoplehospitalised with COVID-19 have been treated withActemra worldwideActemra is approved for this use in more than 30 countries for the treatment of COVID-19Basel, 21 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra ® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalised adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasi...
Source: Roche Media News - December 21, 2022 Category: Pharmaceuticals Source Type: news
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Thepositive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and afavourable safety profile ofHemlibra in people with moderatehaemophilia A without inhibitors1Given that many people with moderatehaemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved,Hemlibra, already approved for severehaemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with afavourable safety profile for people with moderatehaemophilia ABasel, 16 December 2022 - Roche (SIX: RO, ROG...
Source: Roche Media News - December 16, 2022 Category: Pharmaceuticals Source Type: news
Roche announces U.S. collaboration with Pfizer to help patients who test positive for COVID-19 navigate risks, symptoms, testing and treatment options
Testing early for COVID-19 can help determine the proper course of treatment.This collaboration helpspatients access critical resources and locate information about testing, available treatment options, high-risk factors that increase the chance of progressing to severe COVID-19, and ways to seek timely care.The Pilot ® COVID-19 At-Home Test will now include a QR code that directs individuals tocovid19knowmore.com, a Pfizer website, to learn more about testing and treatment options.Basel, 14 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has entered into a U.S. focused collaboration with Pfizer to d...
Source: Roche Media News - December 14, 2022 Category: Pharmaceuticals Source Type: news
Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma
Data showcase the potential ofglofitamab andLunsumio to address diverse patient needsData presented at ASH 2022 andsimultaneouslypublished in theNew England Journal of Medicine showed thatglofitamab, given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma1,227-month follow-up data showedLunsumio continued to induce high and durable responses in people with relapsed or refractory follicular lymphoma, with 60% experiencing a complete response3Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that updated clinical data for its CD20xCD3 T-...
Source: Roche Media News - December 12, 2022 Category: Pharmaceuticals Source Type: news
Roche presents new and updated data for Polivy in previously untreated diffuse large B-cell lymphoma at ASH 2022
Updated data from the phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL)1Patients receivingPolivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes, during and after fixed-duration treatment, to those receiving the current standard-of-care, withsuperiorprogression-free survival2Basel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy ® ...
Source: Roche Media News - December 12, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche: Changes in the Board of Directors and the Corporate Executive Committee
Board of DirectorsBasel, 12 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that at its December meeting, the Board of Directors of Roche Holding Ltd has approved to propose the following changes at the Annual General Meeting on 14 March 2023:As previously announced in July 2022, Christoph Franz has decided not to seek re-election as Chairman. The Board of Directors will propose Severin Schwan as the new Chairman at the Annual General Meeting in 2023, and has appointed Thomas Schinecker as the new Roche Group CEO effective 14 March 2023.The Board of Directors will proposeMark Schneider, CEO of Nestle S.A...
Source: Roche Media News - December 12, 2022 Category: Pharmaceuticals Source Type: news
Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth
The HAVEN 7 studywas designed to further confirm the benefit of preventative treatment (prophylaxis) withHemlibra from birth in previously untreated or minimally treated infants with severehaemophilia A without inhibitorsIn the study, 77.8% of participants had no bleeding episodes that required treatment1In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented2,3Basel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab) achieved meaningful bleed control with a ...
Source: Roche Media News - December 11, 2022 Category: Pharmaceuticals Source Type: news
Roche ’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition
The phase III COMMODORE 3 study ofcrovalimab met primary endpoints of transfusion avoidance andhaemolysis control in people with paroxysmal nocturnal hemoglobinuria (PNH)1COMMODORE 3 is the first China-specific study in PNH. Current treatment options are extremely limited in China, resulting in significant levels of disease-related morbidity and mortality for people living with PNH2Based on these datacrovalimab has received Breakthrough Therapy Designation and is under Priority Review for approval in ChinaBasel, 11 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from the phase III COMMO...
Source: Roche Media News - December 11, 2022 Category: Pharmaceuticals Source Type: news
Roche Alzheimer ’s disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis
TheElecsys® Alzheimer’s disease (AD) CSF assays will be available on thecobas fully automated immunoassay analyzers, enabling patients to get broad access to high quality testing in a timely manner.Greater accessibility and lower cost means these assays could accelerate the path to diagnosis for people with Alzheimer ’s disease.The assays are easily scalable to meet the imminent demand for Alzheimer ’s disease modifying therapies as they become available.Basel, 8 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys ® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P...
Source: Roche Media News - December 8, 2022 Category: Pharmaceuticals Source Type: news
Roche receives U.S. FDA Emergency Use Authorization for its high-throughput test to detect monkeypox virus
In May 2022, Roche was one of the first companies to develop a suite of tests to detect themonkeypox virus and aid in the understanding of why and how the disease is spreading.cobas MPXV for use oncobas 6800/8800 Systems is the firstmonkeypox virus test granted EUA following evaluation in actual patient samples rather than just samples formulated in the laboratory.High-throughput solutions enable rapid results, allowing individuals to avoid additional testing or unnecessary isolation, and supporting access to appropriate treatment as soon as possible.Basel, 16 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced to...
Source: Roche Media News - November 16, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer ’s disease
Phase III GRADUATE studies did not meet their primary endpoints of slowing clinical decline in people with early Alzheimer ’sThe level of beta-amyloid removal bygantenerumab was lower than expectedTopline data will be presented at the Clinical Trials on Alzheimer ’s Disease (CTAD) ConferenceRoche is committed to the Alzheimer ’s community and will continue to develop novel diagnostics and potential treatments for Alzheimer ’sBasel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) du...
Source: Roche Media News - November 14, 2022 Category: Pharmaceuticals Source Type: news
STRONG-HF study results demonstrate clear benefits for acute heart failure patients
STRONG-HF study primary outcomes showed significant reduction of all cause death or acute heart failure readmissions, at day 180, when the study strategy was implementedRapid, simultaneous up-titration of therapies, and close follow-up, led to increased patient quality of life.The RocheElecsys® NT-proBNP biomarker is an integral part of the treatment strategy, comprising rapid up-titration and close follow up after an acute heart failure admissionBasel, 9 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced publication of the Safety, Tolerability and Efficacy of Rapid Optimization of Heart Failure (STRONG-HF...
Source: Roche Media News - November 9, 2022 Category: Pharmaceuticals Source Type: news
Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs
Interim data from phase III HAVEN 7 study reinforceHemlibra ’s efficacy and safety in infants with severehaemophilia A without factor VIII inhibitors1New and updated data support use ofPolivy in diffuse large B-cell lymphoma, including its potential as a treatment option for previously untreated patients2New and updated data for innovative CD20xCD3 T-cell engaging bispecific antibodiesLunsumio andglofitamab further enhance their potential as effective, off-the-shelf, fixed-duration treatment options for people with lymphoma3,4,5,6,7First phase III data forcrovalimab show the co-primary efficacy endpoints were met, with s...
Source: Roche Media News - November 3, 2022 Category: Pharmaceuticals Source Type: news
