[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 Investor Update - April 19, 2023 Category: Pharmaceuticals Source Type: news

[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

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

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

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

FDA accepts supplemental Biologics License Application for Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphomaApplication is based on pivotal data from the phase III POLARIX study showing Polivy plus R-CHP significantly reduced therisk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOPVarious combination studies with Polivy and the company ' s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoingBasel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the compan...
Source: Roche Investor Update - August 16, 2022 Category: Pharmaceuticals Source Type: news

FDA accepts supplemental Biologics License Application for Roche ’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphomaApplication is based on pivotal data from the phase III POLARIX study showing Polivy plus R-CHP significantly reduced therisk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOPVarious combination studies with Polivy and the company ' s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoingBasel, 16 August 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the compan...
Source: Roche Media News - August 16, 2022 Category: Pharmaceuticals 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

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

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