Kymriah Side Effects: Cytokine Release Syndrome, Toxicity, Infections. Last 30 August 2017, the Food and Drug Administration (FDA) approved Kymriah cell therapy to treat children and young adults (up to 25 years of age) with B-cell acute lymphoblastic leukemia.
How is the treatment administered and what side effects should patients be aware of? Apparently, the treatment administration involves the collection of T-cells from the patient, modifying it, and injecting it back. More details from the FDA media release:
The patient’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.
Now, what are the Kymriah side effects that prospective patients should be aware of? According to Novartis, the drug company which developed and markets Kymriah, the treatment can cause Cytokine Release Syndrome which can lead to death:
Cytokine Release Syndrome: Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with KYMRIAH. In Study 1, CRS occurred in 79% (54/68) of patients receiving KYMRIAH, including Grade 3 or 4 (Penn grading system) CRS in 49% (33/68) patients.
Key manifestations of CRS include high fever, lower than normal blood pressure, difficulty breathing, and may be associated with hepatic, renal, and cardiac dysfunction, and coagulopathy.
Neurological toxicities are also observed following treatment with Kymriah. Like CRS, this side effect is also life-threatening:
Neurological toxicities, which may be severe or life-threatening can occur following treatment with KYMRIAH. The majority of neurological toxicities occurred within 8 weeks following KYMRIAH infusion. In Study 1, neurological toxicities within 8 weeks after KYMRIAH infusion occurred in 65% of patients, including Grade 3 or 4 neurological toxicities in 18% of patients, and 75% of events resolved within 12 days.
Other severe Kymriah side effects include serious infections, low blood pressure (hypotension), acute kidney injury, fever, and decreased oxygen (hypoxia).
Because of the above severe side effects — which includes the possibility of death — treatment using Kymriah is available only in select select treatment centers.
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Kymriah Side Effects: Cytokine Release Syndrome, Toxicity, Infections. Posted 13 November 2017.