Welcome to our dedicated page for Roche Hldg news (Ticker: RHHBY), a resource for investors and traders seeking the latest updates and insights on Roche Hldg stock.
Roche Holding Ltd/ADR (RHHBY) is linked to a stream of news that reflects the company’s activities in biotechnology, pharmaceuticals and diagnostics. Recent announcements from Roche and its U.S. affiliate Genentech highlight regulatory approvals, late‑stage clinical trial results, new diagnostic platforms and agreements related to access and manufacturing.
Investors and healthcare observers following RHHBY news will see updates on oncology and haematology programmes, such as the U.S. Food and Drug Administration’s accelerated approval of Lunsumio VELO, a subcutaneous CD20xCD3 bispecific antibody for relapsed or refractory follicular lymphoma after at least two prior lines of systemic therapy. News also covers Phase III data for the investigational oral SERD giredestrant in ER‑positive early‑stage breast cancer, as well as new data on Lunsumio combinations and long‑term outcomes in lymphomas presented at major scientific meetings.
On the diagnostics side, Roche has reported the U.S. launch of next‑generation cobas 6800/8800 systems and software upgrades, CE Mark approval for its cobas Mass Spec solution reagent pack for antibiotics drug monitoring, and CE Mark for the cobas BV/CV assay for bacterial vaginosis and candida vaginitis. These stories illustrate how the company is expanding its in‑vitro diagnostic menu and enhancing laboratory efficiency.
Additional news items include European Commission approval of Gazyva/Gazyvaro for lupus nephritis and Genentech’s agreement with the U.S. government addressing prescription drug costs and direct‑to‑patient programmes. For users of this page, the RHHBY news feed offers a central place to review such regulatory milestones, clinical trial readouts, product launches and policy‑related developments associated with Roche and the Roche Group.
Roche (OTCQX: RHHBY) announced promising data on its investigational therapies for non-Hodgkin lymphoma (NHL) at the 2021 ASCO Annual Meeting. The bispecific antibodies, mosunetuzumab and glofitamab, demonstrated significant treatment responses, with complete response rates of 71.4% and 54.5% respectively in clinical trials. Roche is targeting a regulatory filing for mosunetuzumab in follicular lymphoma by the end of 2021. Approximately 500,000 new NHL cases are diagnosed annually, highlighting the urgent need for new treatment options amid limited existing therapies.
Roche announced the European Commission's approval of Venclyxto (venetoclax) in combination with hypomethylating agents for adults with newly diagnosed acute myeloid leukaemia (AML) ineligible for intensive chemotherapy. The VIALE-A study showed that Venclyxto plus azacitidine improved overall survival, reducing the risk of death by 34%, with median survival of 14.7 months compared to 9.6 months with azacitidine alone. The approval opens new treatment options for AML patients, significantly enhancing complete response rates and overall survival outcomes.
Roche (RHHBY) announced interim results from the Phase III IMpower010 study, indicating that Tecentriq (atezolizumab) significantly improved disease-free survival (DFS) by 34% for patients with PD-L1-positive resectable early-stage lung cancer compared to best supportive care (BSC). Specifically, median DFS was not reached for Tecentriq, while BSC showed 35.3 months. The overall study cohort saw a 21% reduction in recurrence or death risk. Safety outcomes aligned with known profiles, with 92.7% experiencing adverse events. Full results will be presented at the ASCO Annual Meeting.
Genentech, part of Roche, released interim results from the Phase III IMpower010 study, revealing that Tecentriq® (atezolizumab) significantly reduces the risk of disease recurrence or death in patients with Stage II-IIIA non-small cell lung cancer (NSCLC) expressing PD-L1≥1%. Specifically, disease-free survival (DFS) improved by 34% compared to best supportive care (BSC). Median DFS for Tecentriq is yet to be reached, while BSC stands at 35.3 months. The safety profile remained consistent, with adverse events occurring in 92.7% of Tecentriq patients. Full results will be presented at the 2021 ASCO Annual Meeting.
On May 18, 2021, Roche announced that its cobas® SARS-CoV-2 Test received Emergency Use Authorization (EUA) from the FDA for testing asymptomatic individuals, expanding COVID-19 testing to help reduce virus spread. The test can process pooled samples of up to six individuals, supporting CDC guidance amid findings that asymptomatic individuals account for over half of COVID-19 transmissions. Roche previously enabled 160 million molecular tests in 2020 and continues to innovate in diagnostics, emphasizing public health and the safe reopening of communities.
Roche announced new findings from 19 cancer treatments to be presented at the 2021 ASCO Annual Meeting, scheduled for June 4-8, 2021. The data emphasizes patient-centric approaches, particularly for early-stage non-small cell lung cancer (NSCLC) through Tecentriq, which improves disease-free survival. Roche also highlights tumor-agnostic therapies and data in breast and blood cancer treatments. Significant studies, including ALPHA-T and TAPISTRY, focus on personalized care and decentralized trials. Roche aims to enhance treatment accessibility and equity in oncology.
Roche's Tecentriq (atezolizumab) has received European Commission approval as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) exhibiting high PD-L1 expression. This decision presents an alternative to chemotherapy for eligible patients and represents Tecentriq's fourth indication in metastatic NSCLC and fifth in lung cancer overall within the EU. The approval is based on the Phase III IMpower110 study, demonstrating a significant overall survival improvement of 7.1 months compared to chemotherapy. Roche's development program for Tecentriq continues to expand across various cancer types.
Genentech announced that the FDA Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq (atezolizumab) for treating adults with locally advanced or metastatic urothelial carcinoma not eligible for cisplatin chemotherapy and with high PD-L1 expression. This meeting is part of an industry review of accelerated approvals. The FDA has yet to announce a final decision. Tecentriq, approved since 2017, has shown significant efficacy for specific bladder cancer patients, with ongoing studies in various cancers.
On April 28, 2021, Roche (OTCQX: RHHBY) announced that the FDA's Oncologic Drugs Advisory Committee voted 10-1 to maintain the accelerated approval of Tecentriq® for metastatic bladder cancer patients not eligible for cisplatin chemotherapy. This endorsement highlights the significant unmet medical need in this patient population. Roche is committed to advancing Tecentriq's clinical development, having received a similar positive recommendation for triple-negative breast cancer. The FDA's final decision on Tecentriq is pending.
On April 28, 2021, Roche announced five new intended uses for its cardiac biomarkers, Elecsys® cTnT-hs and NT-proBNP, enhancing cardiovascular disease diagnosis and management.
These biomarkers aim to identify cardiovascular risks, improve early diagnosis, and support timely treatments, potentially reducing healthcare costs. Notably, new applications include assessing risks for patients with type-2 diabetes and Atrial Fibrillation.
With over 200 million adults undergoing major non-cardiac surgery annually, these innovations could help predict heart attack risks in surgical patients.