[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche ’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin lymphoma in the USPOLARIX trial showed thePolivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profileFirst-line treatment withPolivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progressionBasel, 19 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that t...
Source: Roche Media News - April 19, 2023 Category: Pharmaceuticals Source Type: news
Update on IMBRUVICA ® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications
HORSHAM, Pa., April 6, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics, an AbbVie Company, announced today the intent to voluntarily withdraw the U.S. indications for IMBRUVICA® (ibrutinib) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. This decision was made in consultation with the U.S. Food and Drug Administration (FDA), c...
Source: Johnson and Johnson - April 6, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Why Some Scientists Believe the Future of Medicine Lies in Creating Digital Twins
Within the walls of a 19th-century chapel on the outskirts of Barcelona, a heart starts to slowly contract. This is not a real heart but a virtual copy of one that still pounds inside a patient’s chest. With its 100 million patches of simulated cells, the digital twin—a fully functional simulation of human anatomy— pumps at a leisurely pace as it tests treatments, from drugs to implants.
This digital twin pulses within MareNostrum, a supercomputer used by scientists to simulate features of the real world. These simulations can look just like the real thing, but they are vastly more sophisticated than Holl...
Source: TIME: Health - April 5, 2023 Category: Consumer Health News Authors: Peter Coveney and Roger Highfield Tags: Uncategorized freelance health Source Type: news
FDA Advisory Committee votes in favour of the clinical benefit of Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
U.S. FDA ’s Oncologic Drugs Advisory Committee voted 11 to 2 in favour of the clinical benefit of the phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma (DLBCL)This is the first treatment in 20 years to show a significant and clinically meaningful improvement in progression-free survival over the standard of care for first-line DLBCLDLBCL is an aggressive, hard-to-treat disease and the most common form of non-Hodgkin lymphoma in the USBasel, 10 March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administrat...
Source: Roche Investor Update - March 10, 2023 Category: Pharmaceuticals Source Type: news
FDA Advisory Committee votes in favour of the clinical benefit of Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
U.S. FDA ’s Oncologic Drugs Advisory Committee voted 11 to 2 in favour of the clinical benefit of the phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma (DLBCL)This is the first treatment in 20 years to show a significant and clinically meaningful improvement in progression-free survival over the standard of care for first-line DLBCLDLBCL is an aggressive, hard-to-treat disease and the most common form of non-Hodgkin lymphoma in the USBasel, 10 March 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administrat...
Source: Roche Media News - March 10, 2023 Category: Pharmaceuticals Source Type: news
What Causes Mediastinal Masses?
Discussion
The mediastinum resides in the chest and is the space bounded by the thoracic inlet cephalically, diaphragm caudally, sternum anteriorly and transverse process of the spine posteriorly, and mediastinal pleura and lungs laterally. It is divided into various compartments:
Superior mediastinum
Bounded by the thoracic inlet cephalically and a horizontal plane passing from the manubriosternal joint to the junction of T4/T5 vertebrae horizontally.
Structures include: esophagus, trachea, parts of great vessels and first branches, great veins and initial branches, thymus, vagus, phrenic and other nerves, thoracic duct...
Source: PediatricEducation.org - February 20, 2023 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news
Netherlands Cancer Institute Tests New Mesothelioma Therapy
Research for a new type of mesothelioma treatment is underway at the Netherlands Cancer Institute. Scientists are exploring a novel combination of existing medications for patients with BAP1 genetic mutations.
More than half of all mesothelioma patients show alterations in the BAP1 tumor-suppressor gene. An altered BAP1 gene allows for vulnerabilities that make specific treatments more effective. The combination treatment led to about a four-week increase in median survival.
Researchers have previously only explored the combination of zoledronic acid and tazemetostat in single cells and animal models. This late...
Source: Asbestos and Mesothelioma News - February 15, 2023 Category: Environmental Health Authors: Amy Edel Tags: Clinical Trials/Research/Emerging Treatments Mesothelioma Source Type: news
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 Investor Update - January 6, 2023 Category: Pharmaceuticals Source Type: news
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 Investor Update - December 23, 2022 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
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 Investor Update - December 12, 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
Real-World Study Shows Patients Treated with IMBRUVICA ® (ibrutinib) Were Less Likely to Initiate a Next-Line Treatment than Patients on Acalabrutinib in First-line Chronic Lymphocytic Leukemia
NEW ORLEANS, December 12, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results of a real-world study showing that patients with chronic lymphocytic leukemia (CLL) treated with first-line acalabrutinib monotherapy were 89 percent more likely to start a next-line treatment than those treated with IMBRUVICA® (ibrutinib).[1] These data suggest the potential that first-line treatment with IMBRUVICA® in routine practice may provide patients with the ability to use once-daily, all-oral IMBRUVICA® as a monotherapy treatment for a longer period without the need to start the next line of ...
Source: Johnson and Johnson - December 12, 2022 Category: Pharmaceuticals Tags: Latest News 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
