Drugs

22 T-Cell Cancers After CAR-T Treatment: CBER

CBER director Peter Marks and Office of Therapeutic Products director Nicole Verdun say that as of 12/31/2023, FDA was aware of 22 cases of T-cell cancers that occurred after treatment with chimeric antigen receptor (CAR) T-cell products. Writing in the New England Journal of Medicine, Marks and Verdun say the cancers have included T-cell lymphoma, T-cell large granular lymphocytosis, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma.

“Among the 14 cases for which adequate data are currently available,” they write, “the cancers have manifested within two years after administration of CAR T cells, with roughly half occurring within the first year after administration. Cases have been reported in conjunction with five of the six available CAR-T products, but the small number of cases and variation in product use preclude conclusions about the strength of an association with any specific product.”

The report says that with more than 27,000 doses of the six approved products having been administered in the U.S., the overall rate of T-cell cancers among people receiving CAR-T therapies appears to be quite low, even if all reported cases are assumed to be related to treatment.

Marks and Verdun say it is important for clinicians caring for people who have received CAR T cells to report the occurrence of any new cancer. They recommend that patients and clinical trial participants who receive treatment with the products be monitored for new cancers throughout their lives.

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