September 7, 2021 PAI Top-10

Roche to present data from industry leading portfolio at ESMO 2021 showing significant progress in early stage and uncommon cancers

First data to be presented from the phase II coopERA Breast Cancer study evaluating neoadjuvant giredestrant treatment for oestrogen receptor (ER)-positive, HER2-negative breast cancer New data from the phase III IMpower010 study provide further insights into the role of Tecentriq® (atezolizumab) in early-stage non-small cell lung cancer (NSCLC) Genomic data from the phase II CUPISCO... Read more

August 27, 2021 Licensing, IP, and Legal

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... Read more

August 18, 2021 Acad, Gov/Utilities Bio/Pharma/CRO Clinical Research/Diagn. PAI Top-10 PR/Corporate

Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy

Cancer is the second leading cause of death worldwide, with nearly 10 million deaths annually.1, 2 In the U.S., approximately 1.9 million new cancer cases are expected to be diagnosed in 2021.1 Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps determine which solid tumour patients may benefit from GSK immunotherapy. Roche/GSK collaboration... Read more

August 9, 2021 Bio/Pharma/CRO PAI Top-10

[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

Pivotal phase III POLARIX trial comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care R-CHOP in treatment of first-line diffuse large B-cell lymphoma (DLBCL) met its primary endpoint of investigator-assessed progression-free survival Prolonging survival without disease advancement could be transformative for newly diagnosed DLBCL patients as currently 40% of patients relapse... Read more

August 3, 2021 Acad, Gov/Utilities

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... Read more

July 29, 2021 Acad, Gov/Utilities

FDA accepts application for Roche’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)

Across four phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in phase III nAMD and DME studies If approved, faricimab would be the first and only medicine designed to target two distinct pathways that drive... Read more

July 29, 2021 Licensing, IP, and Legal Product Launch

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)

FIREFISH Part 2 study showed treatment with Evrysdi helped babies stay free of permanent ventilation, sit without support and improve across a range of motor milestones Evrysdi has proven efficacy in adults, children and babies two months and older with over 4,000 patients treated to date SMA is the leading genetic cause of death in... Read more

July 21, 2021 Acad, Gov/Utilities Other Lab Products/Services PAI Top-10

FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes

Every year in the US, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS), and there remains a high unmet need for new treatment options1 The designation is based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated higher-risk MDS This is the 11th Breakthrough Therapy... Read more

July 20, 2021 Uncategorized

Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

Full approval is based on a global phase III trial which found casirivimab and imdevimab reduced hospitalisation or death by 70% in high-risk non-hospitalised patients 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... Read more