Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
The U.S. Food and Drug Administration (FDA) has released a safety update alerting about a rare yet serious complication linked to the cancer treatment CARVYKTI, following new findings of immune effector cell-associated enterocolitis (IEC-EC) in patients who received the medication.
IEC-EC is a potentially life-threatening inflammatory disorder affecting the gastrointestinal tract. The FDA reports that patients impacted by this condition experienced severe or prolonged diarrhea, abdominal discomfort, and significant weight loss—some even required total parenteral nutrition and immunosuppressive therapies like corticosteroids. In multiple instances, IEC-EC resulted in fatal outcomes, including gut perforation and sepsis.
These reports were uncovered through clinical trials and post marketing surveillance.
Labeling Changes and Safety Updates
In response, the FDA has approved updates to the prescribing information for CARVYKTI, including:
- The addition of IEC-EC risks to the Boxed Warning (also known as the Black Box Warning),
- Updates to Warnings and Precautions and Adverse Reactions – Postmarketing Experience sections,
- Revisions to the Medication Guide provided to patients.
Background and Benefits
CARVYKTI, a CAR-T cell therapy, is approved for adults with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least one line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The recent safety update is based on fresh findings from the CARTITUDE-4 clinical trial, which demonstrated a statistically significant enhancement in overall survival for patients who received CARVYKTI in comparison to those undergoing standard therapy. The median follow-up period was 33.6 months.
In light of the newly identified risks, the FDA underscores that the benefit-risk profile of CARVYKTI continues to be favorable for its authorized applications.
Recommendations for Health Care Providers
The FDA advises that:
- Patients showing signs of IEC-EC should be referred to gastroenterology and infectious disease specialists,
- In treatment-refractory cases, additional evaluation should be done to rule out gastrointestinal T-cell lymphoma, which has been reported in some patients.
The FDA says it will continue to monitor the safety of CARVYKTI and other biologics and is committed to keeping health care professionals and the public informed as new data becomes available.
For more details, clinicians are encouraged to review the updated prescribing information and Medication Guide.
