**Bristol Myers Squibb (BMS) has received approval from the European Commission (EC) for its CD19-directed CAR T cell therapy Breyanzi (lisocabtagene maraleucel) in follicular lymphoma (FL).**
The drug, which is already approved in the EU for certain lymphomas, is now authorised to treat relapsed or refractory FL in adults who have received at least two prior lines of systemic therapy.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 2 TRANSCEND FL study, which demonstrated an overall response rate of 97.1% and a complete response rate of 94.2%, the trial’s primary and key secondary endpoints, respectively.
Responses were rapid and durable, BMS said, with 75.7% of patients still in response at 18 months, and no new safety signals were observed.
FL, which develops when white blood cells cluster together to form lumps in the lymph nodes or organs, accounts for up to 30% of non-Hodgkin lymphoma cases. The disease is considered incurable, with patients often relapsing following front-line therapy and their prognosis worsening after each subsequent relapse.
BMS’ Breyanzi is made from patients’ own T cells, which are collected and genetically re-engineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
Emma Charles, senior vice president, Europe Region, BMS, said: “While significant advancements have been made in the last two decades, there still remains unmet need for patients. Newer treatments for FL, like Breyanzi, have shown impactful results in clinical trials, with the opportunity to deliver lasting results in the routine care setting.”
The announcement comes just days after BMS [received](https://pmlive.com/pharma_news/bms-granted-ec-approval-for-immunotherapy-combination-in-liver-cancer/) EC approval for its dual immunotherapy combination in hepatocellular carcinoma (HCC), the most common type of liver cancer.
Opdivo (nivolumab) plus Yervoy (ipilimumab) was authorised for use as a first-line treatment for adults with unresectable or advanced cases of the disease after results from the late-stage CheckMate-9DW trial demonstrated a statistically significant and clinically meaningful improvement in overall survival with the combination compared to investigator’s choice of lenvatinib or sorafenib.