The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of lisocabtagene maraleucel (lise-cel) for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.
The CHMP opinion is based on data from the phase 2 TRANSCEND FL study, which evaluated patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including enrolled adults with relapsed or refractory follicular lymphoma treated with liso-cel after two or more prior lines of systemic therapy.
In the study, liso-cel demonstrated a high overall response rate of 97.1% (95% CI, 91.7–99.4) and complete response rate of 94.2% (95% CI, 87.8–97.8). The safety of liso-cel is consistent with the well-established safety profile of liso-cel observed across clinical trials, with no new safety signals observed, according to the press release from Bristol Myers Squibb, the manufacturer of the drug.
