Biologics

Immunocore BLA for Melanoma Approved

FDA has approved an Immunocore BLA for Kimmtrak (tebentafusp-tebn) for treating certain adult patients with unresectable or metastatic uveal melanoma (mUM). Approval was based on data from the company’s Phase 3 IMCgp100-202 clinical trial, which evaluated overall survival (OS) of Kimmtrak compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. “Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that Kimmtrak demonstrated unprecedented median OS benefit as a first-line treatment,” the company says.

Kimmtrak is described by Immunocore as a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. It is designed to target gp100, a lineage antigen expressed in melanocytes and melanoma, it says. This is the first therapy developed using Immunocore’s ImmTAC technology platform that is designed to redirect and activate T cells to recognize and kill tumor cells.

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