Tag: Hoffmann-La Roche

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.