Drugs

FDA Updates Carvykti Labeling With Boxed Warning

FDA has approved new labeling for Janssen Biotech’s Carvykti (ciltacabtagene autoleucel, including a Boxed Warning highlighting the risk of immune effector cell-associated enterocolitis (IEC-EC), a potentially life-threatening gastrointestinal complication. The warning comes after the agency reviewed reports from clinical trials and postmarketing data documenting cases of IEC-EC in patients receiving the therapy, an agency update says. Affected patients experienced severe or prolonged diarrhea, abdominal pain, and weight loss, sometimes requiring total parenteral nutrition, it says, adding that in some cases, the condition led to fatal outcomes, including gut perforation and sepsis. Management of IEC-EC often required immunosuppressive therapies such as corticosteroids, along with supportive care.

In addition to the safety update, FDA approved revisions to the product’s Clinical Studies section to include new overall survival data from the CARTITUDE-4 trial, a randomized, multicenter study in adults with relapsed and lenalidomide-refractory multiple myeloma. The trial showed a statistically significant improvement in overall survival for patients treated with Carvykti compared to standard therapy, the update says.

Despite the newly identified risks, the agency concluded that the benefits of Carvykti continue to outweigh potential risks for its approved use. FDA emphasizes that ongoing monitoring of Carvykti and other biologics remains a priority.

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