Biologics

Scancell Advancing iSCIB1+ Into Phase 3 Melanoma Trial

FDA has approved a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+, the company’s lead ImmunoBody immunotherapy, in patients with advanced melanoma. The agency agreed that progression-free survival could act as the surrogate primary endpoint, the company says. The late-stage trial is intended to support potential regulatory approval of iSCIB1+ in unresectable Stage IIIB/IV melanoma.

The decision follows results from Scancell’s 140-patient Phase 2 SCOPE trial, an open-label, multicenter study evaluating SCIB1 and iSCIB1+ in combination with the checkpoint inhibitors nivolumab and ipilimumab in previously untreated advanced melanoma. Based on the Phase 2 data, Scancell selected iSCIB1+ for further development and identified a biomarker-based selection strategy intended to enrich the Phase 3 population for responders, according to the company.

According to updated data from a selected cohort of the SCOPE study, progression-free survival reached 74% at 16 months in patients treated with iSCIB1+ in combination with standard checkpoint therapy. That compares with a reported 50% progression-free survival at 11.5 months for ipilimumab plus nivolumab alone, the current standard of care, based on historical and real-world data, 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

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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