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

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 Investor Update - December 12, 2022 Category: Pharmaceuticals Source Type: news

New Results from the Phase 3 GLOW Study of Fixed-Duration Treatment with IMBRUVICA ® (ibrutinib) Plus Venetoclax Demonstrate Robust Efficacy and Sustained Response in Older, Unfit Patients with Previously Untreated Chronic Lymphocytic Leukemia
NEW ORLEANS, December 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new four-year follow-up results from the Phase 3 GLOW study (Abstract #93), which showed investigational, fixed-duration treatment with IMBRUVICA® + venetoclax (I+V) reduced the risk of progression or death by 79 percent among older and/or unfit patients with previously untreated chronic lymphocytic leukemia (CLL) compared to patients treated with chemoimmunotherapy.[i] These results were highlighted in an oral presentation during the 2022 American Society of Hematology (ASH) Annual Meeting.1CLL is the most com...
Source: Johnson and Johnson - December 10, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

For Camp Lejeune Victims Exposed to Toxic Water, a New Law Promises Compensation —and Closure
Many of Ann Johnson’s life milestones were marked at Camp Lejeune, a sprawling U.S. Marine Corps base camp on the North Carolina coast. She moved to the base in 1982, when her stepfather was stationed there. In 1983, she graduated from Camp Lejeune High School. In 1984, she got married and, at the age of 18, gave birth to her first child at the on-base hospital. Johnson had a difficult pregnancy, gaining 120 pounds due to a complication that leads to excess amniotic fluid. In retrospect, she says, this was the first sign that something was wrong. Then, on the day her daughter, Jacquetta, was born, she didn’t cr...
Source: TIME: Health - November 16, 2022 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized Source Type: news

Seagen Announces U.S. FDA Approval of New Indication for Adcetris (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma
Approval Based on Phase 3 Clinical Study That Demonstrated a 59% Reduction in Risk of Disease Progression or Relapse, Second Malignancy or Death vs. Standard of Care BOTHELL, Wash.--(BUSINESS WIRE) November 10, 2022 --Seagen Inc. (Nasdaq: SGEN)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 10, 2022 Category: Drugs & Pharmacology 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

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 Investor Update - November 3, 2022 Category: Pharmaceuticals Source Type: news

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