Drugs

Boxed Warning Ordered on CAR T-Cell Therapies

FDA has ordered a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The increased warning follows a 11/2023-posted safety communication about reports of T cell malignancies received from clinical trials and postmarketing adverse event data sources.

The Boxed Warning order applies to all six CAR T-cell therapies that were evaluated — Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel), Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleucel), Janssen’s Carvykti (ciltacabtagene autoleucel), Novartis’ Kymriah (tisagenlecleucel), Kite’s Yescarta (axicabtagene ciloleucel) and Kite’s Tecartus (brexucabtagene autoleucel). Additionally, the agency notes that it has required related updates to other sections of the label (Warnings and Precautions, Postmarketing Experience, Patient Counseling Information and Medication Guide) as part of its ongoing safety evaluation.

“Patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies,” the agency update 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

Read more

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