Drugs

FDA OKs ‘Major’ Yescarta, Tecartus REMS Changes

FDA has approved a major modification to the Risk Evaluation and Mitigation Strategy (REMS) for Kite Pharma’s lymphoma drugs Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). An agency notice says FDA has determined that the REMS must be modified to minimize the burden on the healthcare delivery system of complying with it. These are the required modifications:

modification to REMS goals to remove the goal for “ensuring those who prescribe, dispense, or administer Yescarta and/or Tecartus are aware of how to manage the risks of CRS (cytokine release system) and neurological toxicities”;
removal of the requirement for specified educational and training materials; and
removal of the requirement to report any serious adverse events suggestive of CRS or neurological toxicities to the REMS.

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