Biologics

enGene Reports 62% Response Rate for Gene Therapy

enGene says its investigational gene therapy detalimogene voraplasmid produced a 62% complete response rate at six months in patients with high-risk, BCG-unresponsive non–muscle invasive bladder cancer (NMIBC), according to new preliminary data from the company’s Phase 2 LEGEND trial.

The company’s analysis included patients treated under a revised trial protocol adopted in late 2024 to better align with American Urological Association guidelines. Among the 62 patients with at least one post-baseline assessment, detalimogene achieved a 63% complete response (CR) rate at any time, 56% at three months, and 62% at six months among the 37 patients evaluable at that time point, according to the company. All five patients who reached nine months remained in complete response.

“We are pleased to report an improved six-month CR rate for patients being treated with detalimogene under our amended protocol,” enGene says. “With a competitive preliminary efficacy profile and potential for best-in-class tolerability and ease of use, we believe detalimogene could emerge as a first-line therapy for high-risk, BCG-unresponsive NMIBC.”

Additionally, enGene notes that following recent discussions with FDA, the trial’s primary endpoint will shift to CR rate at any time, replacing the previous 12-month landmark CR endpoint. Duration of response will also become a key secondary measure, and the company plans to finalize a statistical analysis plan with the agency to determine the patients included in the evaluable population.

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