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Multiple Myeloma an incurable disease, but I have spent the last 25 years in remission using a blend of conventional oncology and evidence-based nutrition, supplementation, and lifestyle therapies from peer-reviewed studies that your oncologist probably hasn't told you about.
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CAR-T Boxed Warnings
It’s difficult to blog about CAR-T boxed warnings without sounding like I’m anti-CAR-T therapy. I’m not. CAR-T cell therapy holds a great deal of potential for all MM patients and survivors.
My issue has always been that conventional oncology often overlooks the potential benefits of evidence-based non-conventional therapies.
Non-conventional therapies for CAR-T cell therapy, which could be life-saving in certain cases. The video below briefly explains how important the patient’s gut microbiome can be for both the efficacy of CAR-T treatment as well as the toxicity of CAR-T cell therapy.
How changes in the gut microbiome may impact patient response to CAR-T therapy
While I cannot tell MM patients that eating a diverse diet will spare them from developing serious CAR-T cell therapy side effects, I can say that if I were a MM patient about to undergo CAR-T therapy, I would eat healthy microbiome nutrition before, during and after CAR-T cell therapy.
Are you considering CAR-T cell therapy? Email me at David.PeopleBeatingCancer@gmail.com to learn more about managing your MM with both conventional and non-conventional therapies.
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
CAR-T Drug for Myeloma Hit With New Boxed Warning
Immune effector cell-associated enterocolitis can cause life-threatening complications, FDA says
Ciltacabtagene autoleucel (cilta-cel; Carvykti) for multiple myeloma has a new boxed warning opens in a new tab or window for immune effector cell-associated enterocolitis (IEC-EC), the FDA announced on Friday.
Trials and postmarketing adverse event data revealed reports of IEC-EC weeks or months following infusion of the CAR T-cell therapy, including life-threatening and fatal cases from gut perforation and sepsis.
Patients presented with severe or prolonged
- diarrhea,
- abdominal pain,
- and weight loss
that required supportive care, total parenteral nutrition, and various immunosuppressive therapies, including corticosteroids.
“Patients and clinical trial participants with IEC-EC should be managed according to the institutional guidelines including referral to gastroenterology and infectious disease specialists,” the FDA said. “In patients with treatment refractory IEC-EC, additional work-up should be considered to rule out T-cell lymphoma of the gastrointestinal tract which has been reported in patients with treatment refractory IEC-EC in the postmarketing setting.”
Cilta-cel is approved for relapsed and lenalidomide (Revlimid)-refractory multiple myelomaopens in a new tab or window after treatment with at least one line of therapy with an immunomodulatory agent and proteasome inhibitor.
Other boxed warnings on the labeling include risks for
opens in a new tab or window; parkinsonism and Guillain-Barré syndrome; hemophagocytic lymphohistiocytosis/macrophage activation syndrome; prolonged and/or recurrent cytopenias; and secondary hematological malignancies and T-cell malignanciesopens in a new tab or window.
Even with the new boxed warning for IEC-EC, the FDA said it has determined “the overall benefit of Carvykti continues to outweigh the potential risks for the approved use.”
Recent trial data from CARTITUDE-4opens in a new tab or window showing a significant overall survival benefit with second-line cilta-cel in lenalidomide (Revlimid)-refractory patients was also added to the labeling, the FDA said. At a median follow-up of 33.6 months, 76% of those treated with a single infusion of the CAR T-cell product were still alive versus 60.7% of those assigned to standard therapy.
CAR-T cell boxed warnings CAR-T cell boxed warnings CAR-T cell boxed warnings