Drugs

FDA Clinical Hold on Cell Therapy After Patient Dies

FDA has placed a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN). The hold was ordered after the company reported one death in the BPDCN clinical trial (ABC study). This was the first patient treated, a 78-year-old male treated with one prior therapy. He experienced a grade 2 Cytokine Release Syndrome and a grade 3 lung infection on day five, and then developed a grade 4 Capillary Leak Syndrome on day eight, according to the company.

The first patient treated in the AML study was a 58-year-old woman who received the same preconditioning regimen and the same dose of UCART123 as the BPDCN patient, Cellectis says. She experienced an initial grade 2 Cytokine Release Syndrome on day eight, worsening to a grade 3 on day nine, and resolving on day 11 after treatment in an intensive care unit. She also experienced a grade 4 Capillary Leak Syndrome on day 9, which was resolved on day 12, it says.

A data safety monitoring board met on 8/28 and recommended lowering the dose in both studies. Cellectis says it is working closely with clinical investigators and FDA to resume the trials with an amended protocol including a lowered dosing of UCART123.

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