Roche Holding Ltd. (RHHBY) reports healthcare developments across medicines, diagnostics and digital health, including updates from Genentech as a member of the Roche Group. Recurring news covers operating and financial results, regional sales trends, product performance and regulatory disclosures tied to the company’s pharmaceutical and diagnostic portfolios.
Company updates frequently feature ophthalmology products and pipeline assets such as Vabysmo, Susvimo and vamikibart across retinal conditions including diabetic macular edema and neovascular age-related macular degeneration. Roche also reports clinical data in neurology and autoimmune disease, including fenebrutinib in multiple sclerosis and ENSPRYNG in myelin oligodendrocyte glycoprotein antibody-associated disease, along with diagnostics approvals and patient-education initiatives.
On March 14, 2023, Roche (OTCQX: RHHBY) held its Annual General Meeting, where all proposals by the Board of Directors were approved, including the election of Severin Schwan as the new Chairman. Thomas Schinecker was appointed as the new CEO. Shareholders approved a dividend increase to CHF 9.50 per share, marking the 36th consecutive rise. The meeting also ratified the actions of the Board and authorized future remuneration for its members. KPMG AG was appointed as the external auditor for 2023. The company continues to focus on enhancing healthcare outcomes through innovative diagnostics and pharmaceuticals.
Genentech, part of the Roche Group, received an 11 to 2 vote from the FDA’s Oncologic Drugs Advisory Committee in favor of Polivy (polatuzumab vedotin-piiq) combined with R-CHP for treating untreated diffuse large B-cell lymphoma (DLBCL). This marks the first treatment in 20 years to show significant improvement in progression-free survival over standard therapy. The FDA will decide on the supplemental Biologics License Application by April 2, 2023. Polivy has already been approved in over 60 countries for DLBCL. With findings indicating a 27% reduction in disease progression compared to R-CHOP, this treatment offers new hope for DLBCL patients.
The U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favor of Roche's Polivy (polatuzumab vedotin-piiq) combined with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). This marks the first groundbreaking treatment in two decades, showing significant improvement in progression-free survival against the standard R-CHOP. The FDA is expected to decide on the supplemental application by April 2, 2023. DLBCL, the most prevalent form of non-Hodgkin lymphoma, has seen limited advancements in treatment outcomes. Polivy's combination therapy was also recognized as a preferred option in NCCN Clinical Practice Guidelines.
Roche announces FDA approval for the VENTANA PD-L1 (SP263) Assay, enabling identification of non-small cell lung cancer (NSCLC) patients eligible for Libtayo treatment. This approval expands access to immunotherapy for patients with locally advanced and metastatic NSCLC, a group comprising over 60% of NSCLC diagnoses.
The assay is vital for guiding clinical decisions and optimizing patient outcomes. It is uniquely positioned as the only FDA-approved product for NSCLC across four immunotherapy options, aimed at improving treatment pathways for lung cancer, which remains the leading cause of cancer death worldwide.
Roche has received FDA approval for the VENTANA PD-L1 (SP263) Assay, enhancing access to Libtayo (cemiplimab) for patients with non-small cell lung cancer (NSCLC). This assay identifies those eligible for treatment, expanding options for over 60% of diagnosed NSCLC patients at advanced stages. This advancement is crucial as lung cancer remains the top cause of cancer deaths globally, with over 2.2 million diagnoses annually.
The VENTANA assay is unique, providing indications for four different immunotherapies, and underpins the importance of personalized medicine in improving patient outcomes.
Roche has expanded its collaboration with the U.S. Centers for Disease Control and Prevention (CDC) to enhance laboratory capabilities in regions severely impacted by HIV and tuberculosis. This initiative, known as Lab Networks for Health, aims to improve detection, prevention, and treatment outcomes in selected African, Eastern European, and Central Asian countries. The partnership will focus on workforce development, quality management systems, and multi-pathogen testing. With approximately 2 billion people infected with tuberculosis and over 38 million living with HIV, strengthening laboratory networks is essential for public health.
Roche (OTCQX: RHHBY) announced an expanded partnership with the U.S. CDC, aiming to strengthen laboratory capabilities in countries impacted by HIV and tuberculosis. The "Lab Networks for Health" initiative focuses on enhancing diagnostics and treatment outcomes through public-private collaboration in Africa, Eastern Europe, Central Asia, and the Western Hemisphere. Key efforts include workforce training, quality management systems, and optimizing diagnostic networks for better pandemic preparedness. This collaboration is crucial as global health challenges persist, evidenced by millions undiagnosed with HIV and TB. The initiative supports WHO goals for disease elimination.
Roche has launched the IDH1 R132H and ATRX Rabbit Polyclonal Antibodies to enhance the diagnosis of brain cancer mutations. These additions to Roche's neuropathology portfolio aim to improve patient care by enabling clinicians to stratify treatments based on IDH1 and ATRX gene mutation statuses. The IDH1 R132H mutation is linked to better prognosis and eligibility for clinical trials. These tests, optimised for the BenchMark series, are designed to be more accurate and cost-effective than traditional sequencing methods. Initially available in the US, they will expand to other markets later this year and in 2024.
On February 10, 2023, Roche (OTCQX: RHHBY) announced its Roche Long Term Foundation acquired 540,000 bearer shares through an accelerated book building process. This acquisition is intended to meet both current and future obligations from equity compensation plans. The sale also involved a member of a shareholder group, which sold 2.7 million shares, reducing their ownership from 67.5% to approximately 65% of Roche's total issued shares. Roche continues to be a leader in biotechnology and diagnostics and has been recognized for its sustainability efforts in the pharmaceuticals industry.
Roche reported positive data for Vabysmo (faricimab) from two phase III trials, BALATON and COMINO, evaluating its efficacy for macular edema due to retinal vein occlusion (RVO). In both trials, Vabysmo achieved non-inferior visual acuity gains compared to aflibercept. The studies showed a significant reduction in retinal fluid, indicating effective treatment outcomes. If approved, RVO will be the third indication for Vabysmo, which is already authorized for neovascular age-related macular degeneration and diabetic macular edema. The findings will be submitted for regulatory review globally, including by the FDA and EMA.