Drugs

REMS Requirements Ended for CAR T Cell Therapies

In a move to reduce burdens on healthcare providers and improve patient access, FDA is removing risk evaluation and mitigation strategies (REMS) requirements for all currently approved BCMA- and CD19-directed autologous CAR T cell therapies, explaining that the programs are no longer necessary to ensure patient safety. The action affects the following six FDA-approved CAR T therapies:

Celgene’s Abecma (idecabtagene vicleucel)
Juno Therapeutics’ Breyanzi (lisocabtagene maraleucel)
Janssen Biotech’s Carvykti (ciltacabtagene autoleucel)
Novertis’ Kymriah (tisagenlecleucel)
Kite Pharmaceuticals’ Tecartus (brexucabtagene autoleucel)
Kite Pharmaceuticals’ Yescarta (axicabtagene ciloleucel)

Those REMS programs were intended to address the risk of serious side effects, including cytokine release syndrome (CRS) and neurological toxicities, according to the agency. Hospitals and clinics were required to undergo special certification and maintain immediate access to the drug tocilizumab, used to manage severe side effects, it says.

In a just-posted safety communication, FDA says it has approved updated prescribing information and medication guides for the six therapies. Key changes include:

Continued recommendation to monitor patients for at least two weeks after infusion, with daily checks for the first week.
Advising patients to stay within close proximity of a healthcare facility for two weeks post-treatment.
Recommending patients avoid driving for two weeks after administration.

FDA notes that removing the REMS does not change FDA’s post-marketing safety requirements. Manufacturers must continue monitoring for long-term safety outcomes, including secondary cancers, with patient follow-up extending 15 years. Standard adverse event reporting also remains in effect under current regulations.

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