Drugs

Kite Labeling Update on Yescarta with Corticosteroids

FDA has approved a Kite labeling update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects. the company said.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy currently indicated for treating adult patients with relapsed or refractory large B-cell lymphoma and adult patients with relapsed or refractory follicular lymphoma.

The label update is based on data from a new safety management cohort (Cohort 6) of the pivotal ZUMA-1 study, which was designed to assess corticosteroids’ prophylactic impact and earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome (CRS) and neurologic events, according to kite. In the cohort, no Grade 3 or higher CRS events occurred in patients taking corticosteroids.

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