Tag: Hoffmann-La Roche

Regulatory Approval Autoimmune Diseases News

Roche’s Gazyva/Gazyvaro Gets U.S. FDA Approval for Lupus Nephritis Treatment

Roche

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis. Based on positive results from Phase II and III clinical trials, this new therapy offers a significant advancement for those suffering from this severe kidney complication of lupus, showing superiority over standard therapy alone.

Oncology News

ESMO 2025 Preview: Roche, Lilly, AbbVie, and Gilead to Present Latest Oncology Data

ESMO_2025

Leading pharmaceutical companies including Roche, Eli Lilly, AbbVie, and Gilead/Kite are set to present significant new data from their oncology pipelines at the ESMO Congress 2025 in Berlin (Oct 17-21). Presentations will highlight advancements in targeted therapies, ADCs, and cell therapy for multiple cancer types, focusing on key drugs like Tecentriq, Verzenio, and Trodelvy.

Regulatory Approval News Oncology

FDA Approves Groundbreaking Combination Therapy for Extensive-Stage Small Cell Lung Cancer

Roche

In a major breakthrough for oncology, the U.S. FDA has approved a new combination therapy from Roche for a highly aggressive form of lung cancer. The treatment, which combines Tecentriq® (atezolizumab) and lurbinectedin (Zepzelca®), is the first of its kind for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). Clinical trial results show the regimen significantly reduces the risk of disease progression and death, offering new hope and a pivotal shift in how this challenging disease is managed post-chemotherapy.

Clinical Trials Autoimmune Diseases Healthcare & Pharmaceuticals News

Roche Highlights New OCREVUS® Data Demonstrating Benefit in Diverse MS Populations and Presents Promising Long-Term Fenebrutinib Results at ECTRIMS 2025

Roche

Roche is set to present a wealth of new data at the 41st ECTRIMS Congress, highlighting the expanding benefits of its flagship multiple sclerosis therapy, OCREVUS® (ocrelizumab). New findings demonstrate a significant reduction in disability progression for adults with advanced primary progressive MS (PPMS) and reinforce its safety for pregnant women and their infants. The presentation will also include the first comparative data for OCREVUS in pediatric MS. Alongside these updates, Roche will showcase promising two-year results for its investigational oral BTK inhibitor, fenebrutinib, which showed near-complete suppression of disease activity in patients with relapsing MS ahead of pivotal Phase III readouts.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Roche’s Giredestrant Combination Shows Significant Benefit in Advanced ER-Positive Breast Cancer

Roche

Roche’s Phase III evERA study for the investigational drug giredestrant has delivered positive results, showing a significant improvement in progression-free survival for patients with advanced ER-positive breast cancer. The all-oral combination therapy, which was well-tolerated, offers a new, promising treatment option for individuals whose disease has progressed after previous treatments.

Regulatory News

FDA Rejects Genentech’s Bid to Expand Use of Lymphoma Drug Columvi

Roche

Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Regulatory Approval Healthcare & Pharmaceuticals News

U.S. FDA Approves Roche’s Susvimo for Diabetic Retinopathy, Offering New Hope for Millions

Roche

Roche’s Susvimo® has received FDA approval for diabetic retinopathy, becoming the first continuous delivery treatment offering sustained vision benefits with just one refill every nine months. Backed by strong Phase III results, the implant provides a long-term solution for millions at risk of vision loss.