Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020

People with muscle-invasive urothelial cancer (MIUC) who had detectable circulating tumour DNA (ctDNA) were more likely to benefit from treatment with adjuvant (after surgery) Tecentriq monotherapy, compared with those without ctDNA The goal of current treatment in people with MIUC is to provide early intervention to reduce the risk of the disease recurring or spreading... Read more

Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials

Moderna’s vaccine triggers an antibody response to the SARS-CoV-2 spike protein The Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants and could help to establish correlation to protection from COVID-19 Emergency Use Authorisation by the US FDA for the Elecsys Ab test was granted on 25... Read more

New data presented at ASH 2020 reinforces the benefit/risk profile of fixed-duration Polivy plus bendamustine and MabThera/Rituxan in patients with relapsed or refractory diffuse large B-cell lymphoma

Basel, 07 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced longer-term data from the pivotal phase Ib/II GO29365 study, including data from a single-arm extension cohort of 106 additional patients, which show the benefit of Polivy® (polatuzumab vedotin) plus bendamustine and MabThera®/Rituxan® (rituximab) (BR) in people with relapsed or refractory (R/R) diffuse... Read more

New follow-up phase III data reinforce the long-term benefit of Roche’s Hemlibra for people with haemophilia A

Basel, 7 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra® (emicizumab).[1] These data, from adults, adolescents and children with haemophilia... Read more

Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia

             Basel, 5 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD).... Read more

Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy,... Read more

Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies

Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the... Read more

FDA approves Xolair® (omalizumab) for adults with nasal polyps

Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation Xolair is now FDA-approved across three diseases and in two formulations, continuing to build on the medicine’s 17 years of patient experience since its initial approval for allergic asthma              Basel, 01 December... Read more