New Phase III data support the benefit of Roche ’s Tecentriq in early-stage lung cancer
Basel, 20 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq ® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease re currence or death (DFS) by 34% ...
Source: Roche Media News - September 20, 2021 Category: Pharmaceuticals Source Type: news
Roche receives positive CHMP opinion for Gavreto ® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
Basel, 17 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated w ith a RET inhibitor. (Source: Roche Media News)
Source: Roche Media News - September 17, 2021 Category: Pharmaceuticals Source Type: news
Roche opens access to pathology imaging tools to improve patient care
Basel, 15 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the introduction of theRoche Digital Pathology Open Environment that allows software developers to easily integrate their image analysis tools for tumour tissue with Roche ’s uPath enterprise software, an application for pathologist workflow. This open environment allows for the secure exchange and flow of data so that pathologists can access advanced algorithms from third parties alongside Roche’s menu of artificial intelligence-based image analysis tools. This e nables software developers globally to distribute their digital products throug...
Source: Roche Media News - September 15, 2021 Category: Pharmaceuticals Source Type: news
Roche signs definitive share purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases
Basel, 09 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group. Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021. (Source: Roche Media News)
Source: Roche Media News - September 9, 2021 Category: Pharmaceuticals Source Type: news
Roche to present data from industry leading portfolio at ESMO 2021 showing significant progress in early stage and uncommon cancers
Basel, 07 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new oncology data will be presented at the European Society for Medical Oncology (ESMO) Congress, which will be held 16-21 September, 2021. With one of the broadest oncology pipelines and portfolios in the industry, Roche presentations include late-breaking abstracts featuring data in early-stage breast cancer and early-stage lung cancer, and a presentation on cancer of unknown primary (CUP), which has been selected for inclusion in the ESMO Press Programme. (Source: Roche Media News)
Source: Roche Media News - September 7, 2021 Category: Pharmaceuticals Source Type: news
Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer
Basel, 27 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq ® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by a US Food and Drug Administration (FDA)-approved test. Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatme...
Source: Roche Media News - August 27, 2021 Category: Pharmaceuticals Source Type: news
Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy
Basel, 18 August 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company ' s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. The VENTANA MMR RxDx Panel is the first companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (MMR), who may be eligible for JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GSK. The test evaluates a panel of MMR pro...
Source: Roche Media News - August 18, 2021 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Phase III study shows Roche's Polivy plus R-CHP is the first regimen in 20 years to significantly improve outcomes in previously untreated aggressive form of lymphoma compared to standard of care
Basel, 9 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the pivotal phase III POLARIX trial investigating Polivy ® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) versus MabThera/Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), met its primary endpoint by demonstrating significantly improved an d clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Safety outcomes were consistent with those seen in previous trials....
Source: Roche Media News - August 9, 2021 Category: Pharmaceuticals Source Type: news
US FDA grants Priority Review to Roche ’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer
Basel, 3 August 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-appro ved test. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective ...
Source: Roche Media News - August 3, 2021 Category: Pharmaceuticals Source Type: news
FDA accepts application for Roche ’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.Faricimab will be the first and only bispecific antibody designed for the eye, if approved. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) ...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news
Data for Roche ’s Evrysdi® (risdiplam) published in New England Journal of Medicine shows significant improvement in survival and motor milestones in babies with Type 1 spinal muscular atrophy (SMA)
Basel, 29 July 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the New England Journal of Medicine (NEJM) has published data from FIREFISH Part 2, a pivotal global study evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies aged 1-7 months old with symptomatic Type 1 spinal muscular atr ophy (SMA). The study met its primary endpoint with 29% of infants (12/41) sitting without support for at least five seconds* by month 12, a milestone not seen in the natural course of the disease. Safety for Evrysdi in the FIREFISH Part 2 study was consistent with its known safety profile.“Without treatme...
Source: Roche Media News - July 29, 2021 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good half-year results
Commenting on the Group ’s performance in the first six months, Roche CEO Severin Schwan said: “We have achieved good results in the first half, primarily thanks to the demand for our new medicines and COVID-19 tests. (Source: Roche Media News)
Source: Roche Media News - July 22, 2021 Category: Pharmaceuticals Source Type: news
FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes
Basel, 21 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta ® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the rev ised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells.2 This can lead to weakness, frequent infections, anaemia and deb...
Source: Roche Media News - July 21, 2021 Category: Pharmaceuticals Source Type: news
Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
Basel, 20 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan ’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals an d Medical Devices Act. (Source: Roche Media News)
Source: Roche Media News - July 20, 2021 Category: Pharmaceuticals Source Type: news
New data for Roche ’s Hemlibra reinforce safety profile in people with haemophilia A
Basel, 19 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the final analysis of the phase IIIb STASEY study, which confirm the favourable safety profile of Hemlibra ® (emicizumab), consistent with the phase III HAVEN clinical programme.1,2,3,4 In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with haemophilia A with inhibitors to factor VIII, the clotting protein that is missing or defective in people with haemophilia A. The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congre...
Source: Roche Media News - July 19, 2021 Category: Pharmaceuticals Source Type: news
