The Food and Drug Administration (FDA) has updated safety labeling for Johnson & Johnson's (NYSE:JNJ) Carvykti after receiving reports of immune effector cell-associated enterocolitis (IEC-EC)—a rare but serious complication seen in both clinical trials and postmarketing data.
The condition has been linked to fatal cases of gut perforation and sepsis, with patients experiencing severe diarrhea, abdominal pain, and weight loss that often required total parenteral nutrition and immunosuppressive therapy.
The agency has added IEC-EC to Carvykti's Boxed Warning and advised that affected patients be managed per institutional protocols, including referral to gastroenterology and infectious disease specialists.
In treatment-refractory cases, clinicians should rule out T-cell lymphoma of the gastrointestinal tract, which has been reported postmarketing.
The FDA also approved updates to the drug's Clinical Studies section. The agency added new overall survival (OS) data from the CARTITUDE-4 trial, which showed a statistically significant OS improvement for Carvykti-treated patients with relapsed and lenalidomide-refractory multiple myeloma after a median follow-up of 33.6 months.
Regulators affirmed that the therapy's benefits continue to outweigh its risks. Separately, Johnson & Johnson is reportedly in talks to acquire Protagonist Therapeutics (NASDAQ:PTGX). The two companies partnered to develop an oral treatment for plaque psoriasis and ulcerative colitis, according to media reports Friday.
Price Action: JNJ stock is down 0.70% at $189.38 during the premarket session at the last check on Monday.
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