Drugs

Roche’s Giredestrant Combo Shows Positive Phase 3 Data

Roche says new data from the Phase 3 evERA Breast Cancer study show its investigational oral therapy giredestrant, used in combination with everolimus, significantly improved progression-free survival (PFS) in patients with estrogen receptor-positive, HER2-negative advanced breast cancer.

According to the data, the combination reduced the risk of disease progression or death by 44% in the overall study population and by 62% among patients with ESR1 mutations, compared with standard-of-care endocrine therapy plus everolimus. The results were recently presented at the European Society for Medical Oncology Congress 2025.

“This is the first positive head-to-head Phase 3 trial testing a selective estrogen receptor degrader regimen against a standard-of-care combination,” Roche says in a statement. The company plans to share the data with global health authorities, with the goal of bringing the treatment to patients “as soon as possible.”

In the trial’s intent-to-treat population, median PFS reached 8.8 months with the giredestrant combination versus 5.5 months for standard therapy, according to the company. Among patients with ESR1 mutations, median PFS was 10.0 months in giredestrant-treated patients versus 5.5 months in those on standard therapy. Although overall survival data are still immature, Roche reports a positive trend favoring the giredestrant regimen in both the overall and ESR1-mutated populations.

Adverse events were described as manageable and consistent with the known profiles of the individual drugs. No new safety signals were identified, including no cases of photopsia (visual disturbances), the company says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome