Biologics

Inhaled Gene Therapy for Lung Cancer Gets ‘Expedited’ Status

FDA has granted Krystal Biotech a Regenerative Medicine Advanced Therapy (RMAT) designation for KB707, an inhalable gene therapy being investigated for treating advanced or metastatic non-small cell lung cancer (NSCLC). KB707 is described as a redosable herpes simplex type 1 virus-based immunotherapy that is designed to deliver genes directly into a tumor to produce IL-2 and IL-12 cytokines.

“The FDA’s decision to grant RMAT designation to KB707 reflects both the urgent unmet need for new NSCLC therapies as well as the promising early clinical evidence of efficacy we have observed with inhaled KB707 in patients with advanced NSCLC,” the company says.

The designation is based on early clinical data from the ongoing Phase 1 KYANITE-1 study in patients with heavily pre-treated advanced NSCLC. According to the company, the trial has demonstrated consistent and meaningful antitumor activity, including durable responses and clinically significant tumor reductions in patients receiving inhaled KB707. Enrollment in the KYANITE-1 trial (NCT06228326) remains ongoing. Krystal says additional data will be presented at upcoming scientific meetings.

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