Home / Business and Economy / FDA Slaps Strictest Warning on J&J's Cancer Drug Carvykti
FDA Slaps Strictest Warning on J&J's Cancer Drug Carvykti
14 Oct
Summary
- FDA adds severe warning label to J&J's cancer drug Carvykti
- Carvykti linked to fatal gut infections in some patients
- J&J set to report Q3 earnings amid stock's 35% YTD gain
On October 14, 2025, the U.S. Food and Drug Administration (FDA) announced that it has ordered Johnson & Johnson (J&J) to add a severe warning label to its cancer treatment drug Carvykti. The warning states that the medication could have a fatal impact on patients' stomachs or intestines.
This is the strictest type of warning the FDA can issue for a drug. The agency made the decision after receiving reports that some patients developed a serious bacterial infection called IEC-EC after being treated with Carvykti's intravenous infusion. IEC-EC can cause diarrhea, stomach pain, and fever.
Despite the new safety concerns, the FDA maintains that the overall benefits of Carvykti still outweigh the risks for patients with multiple myeloma, a type of blood cancer. Carvykti, which was jointly developed by J&J and Legend Biotech, received FDA approval in March 2022 as a cell-based therapy to treat this condition.
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The warning label news comes as J&J prepares to release its third-quarter financial results on October 15, 2025. Wall Street analysts expect the healthcare giant to generate $23.76 billion in revenue and earnings of $2.76 per share for the quarter. Interestingly, J&J's stock has managed to gain around 35% so far this year, bucking the broader bearish trend in the healthcare sector.
