Drugs

FDA Modifies CAR T Cell REMS

FDA says it has determined that the Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies must be modified to minimize the burden on the healthcare delivery system. An online post says currently, the risks for CAR T cell immunotherapies can be conveyed adequately through the current product labeling, which includes a Boxed Warning for the risks of cytokine release syndrome (CRS) and neurological toxicities, and the Medication Guides that are a part of the approved labeling.

“REMS have been modified to remove requirements for educational and training materials,” the notice says. “Additionally, the requirement to report adverse events suggestive of CRS or neurological toxicities to the REMS has been removed. Adverse event reporting requirements in accordance with [regulations] are adequate for continued routine safety monitoring for these products.”

FDA says the goal of the modified REMS is to mitigate the risks of CRS and neurological toxicities by ensuring that hospitals and their associated clinics that dispense the six listed products are specially certified and have on-site, immediate access to tocilizumab, used to treat CAR T-related CRS.

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