Drugs

NovaBridge Says FDA Open to Accelerated Approval for Givastomig

FDA has told NovaBridge Biosciences that its investigational cancer therapy givastomig could be eligible for an accelerated approval pathway following a recent Type B regulatory meeting. The company says written minutes from the meeting confirmed the agency’s willingness to consider accelerated approval for the drug in first-line treatment of patients with HER2-negative, Claudin 18.2–positive, PD-L1–positive gastroesophageal cancer.

NovaBridge plans to launch a registrational Phase 3 trial of givastomig in combination with immunochemotherapy as early as the fourth quarter of 2026. The study is expected to use objective response rate as the primary endpoint to support a potential accelerated approval filing, with final design details to be finalized in discussions with regulators.

Givastomig is a bispecific antibody designed to target Claudin 18.2 on tumor cells while activating T cells through the 4-1BB immune signaling pathway, according to the company. The therapy is being developed as a potential first-in-class treatment for gastric and other gastrointestinal cancers expressing the Claudin 18.2 biomarker.

According to the company, data from a Phase 1b dose-expansion trial evaluating givastomig in combination with immunochemotherapy showed a 75% objective response rate among 52 evaluable patients. Responses were observed across a range of PD-L1 and Claudin 18.2 expression levels.

Investigators also reported a median progression-free survival of 16.9 months and an 82% six-month progression-free survival rate among 53 evaluable patients. The company says the therapy demonstrated favorable tolerability without evidence of dose-dependent toxicity.

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