Drugs

Summit’s Ivonescimab Outperforms Tislelizumab in Trial

Summit Therapeutics is reporting that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significantly reduced the risk of disease progression or death by 40% compared with tislelizumab (BeiGene’s Tevimbra) plus chemotherapy in the Phase 3 HARMONi-6 trial for first-line treatment of patients with advanced squamous non-small cell lung cancer.

The data, generated by Summit’s partner Akeso and presented at the European Society for Medical Oncology Congress 2025 in Berlin, mark the first known instance in which a PD-(L)1/VEGF bispecific antibody regimen has demonstrated a clinically meaningful advantage over an anti–PD-1 plus chemotherapy combination in a head-to-head Phase 3 setting, according to the company. It says patients treated with ivonescimab plus chemotherapy achieved a median progression-free survival (PFS) of 11.1 months, compared to 6.9 months for those receiving tislelizumab plus chemotherapy. The overall response rate was 75.9% versus 66.5%.

Safety was comparable between arms, with similar rates of serious treatment-related adverse events and discontinuation, Summit says, adding that Grade 3 or higher VEGF-related side effects, including hypertension and proteinuria, occurred slightly more often in the ivonescimab arm but were largely manageable.

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

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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