[4] The most common adverse reactions for treating follicular lymphoma include cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation, and fever.
[3][6] In May 2024, the US Food and Drug Administration (FDA) expanded the indication for lisocabtagene maraleucel to include adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy;[7][9] and the treatment of adults with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
[10] The US Food and Drug Administration (FDA) prescription label carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR-T cells, causing high fever and flu-like symptoms and neurologic toxicities.
[11] Lisocabtagene maraleucel's safety and efficacy were established in a multicenter clinical trial of more than 250 adults with refractory or relapsed large B-cell lymphoma.
[6] Efficacy was evaluated in TRANSFORM (NCT03575351), a randomized, open-label, multicenter trial in adults with primary refractory large B-cell lymphoma or relapse within twelve months of achieving complete response (CR) to first-line therapy.
[12] Efficacy was also evaluated in PILOT (NCT03483103), a single-arm, open-label, multicenter trial in transplant-ineligible patients with relapsed or refractory large B-cell lymphoma after one line of chemoimmunotherapy.