In May 2022, the FDA approved the CAR T-cell therapy Kymriah (tisagenlecleucel; from Novartis) for adults with follicular lymphoma that either relapsed (returned) after or did not respond (refractory) to 2 or more systemic therapies. Kymriah is a type of immunotherapy called CAR T-cell therapy, which involves using the patient’s own cells to modify the cells genetically and then infuse them back into the patient to destroy the cancer.
“The approval of Kymriah offers patients with relapsed or refractory follicular lymphoma a new treatment option and new hope for improving patient outcomes,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “Having this single infusion treatment option helps to transform the way healthcare providers approach this type of blood cancer.”
The approval was based on the results of a clinical trial of 90 patients with follicular lymphoma who received 2 or more systemic therapies or whose cancer returned after undergoing stem-cell transplant.
Of the 90 patients, more than three-quarters (86%) had a response to Kymriah, including 68% of patients who had a complete response (no sign of cancer). After 9 months, three-quarters (75%) of those with a response were still responding to Kymriah.
The most common side effects reported in this study with Kymriah were cytokine-release syndrome, infection, fatigue, musculoskeletal pain, headache, and diarrhea.
