European Commission approves label expansion of Roche ’s Hemlibra to include people with moderate haemophilia A in the EU
Hemlibra, already approved for severe haemophilia A in the EU, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia AModerate haemophilia A can have a significant impact on the lives of people affected, with only 15% living a bleed-free life1The approval is based on the HAVEN 6 results, whereHemlibra demonstrated effective bleed control and a favourable safety profile in people with moderate haemophilia A without inhibitors2Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the He...
Source: Roche Media News - February 1, 2023 Category: Pharmaceuticals Source Type: news
ODAC to Review Lymphoma Drug; Tobacco Control; Artificial Skin Aids Cancer Studies
(MedPage Today) -- The FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will meet March 9 to review the accelerated approval of polatuzumab vedotin (Polivy) plus rituximab (Rituxan) and chemotherapy for untreated diffuse large B... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - January 27, 2023 Category: Hematology Source Type: news
Dr Reddy's completes clinical studies of its proposed rituximab biosimilar candidate
Following completion of the full set of clinical studies, Dr Reddy's said it will now prepare to file in the US, European Union and other regions for approval of 'DRL_RI'. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 20, 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 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
Key Data in Non-Hodgkin Lymphoma From ASH 2022 Key Data in Non-Hodgkin Lymphoma From ASH 2022
The best consolidation therapy in CNS lymphoma, bispecific antibodies, and rituximab vs watch and wait are among top picks in non-Hodgkin lymphoma from ASH 2022, reported by Dr Michael Bishop.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 3, 2023 Category: Consumer Health News Tags: Hematology-Oncology ReCAP 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
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
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 Investor Update - December 16, 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
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
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
