EC Approves Breyanzi for Follicular Lymphoma by Bristol Myers Squibb

Bristol Myers Squibb (BMS) has achieved a significant milestone with the European Commission (EC) granting approval for its CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), targeting CD19 in follicular lymphoma (FL). This approval extends the drug's use to adult patients with relapsed or refractory FL who have undergone at least two prior systemic treatments. This decision aligns with a recent endorsement from the European Medicines Agency’s human medicines committee and is supported by promising outcomes from the phase 2 TRANSCEND FL study. The study highlighted an impressive overall response rate of 97.1% and a complete response rate of 94.2%, which served as the trial's primary and key secondary endpoints, respectively.

BMS reported that responses to Breyanzi were both rapid and sustained, with 75.7% of patients maintaining their response 18 months into the treatment. Importantly, no new safety concerns emerged during the trial. Follicular lymphoma, responsible for up to 30% of non-Hodgkin lymphoma cases, arises when clusters of white blood cells form in the lymph nodes or organs. This condition is considered incurable, with frequent relapses after initial treatment, and the outlook worsens with each recurrence.

Breyanzi offers a novel approach as it is developed from a patient's own T cells. These cells are harvested and genetically modified to become CAR T cells, which are then infused back into the patient as a single-dose therapy. Emma Charles, senior vice president of the Europe Region at BMS, emphasized the advancements in treatment over the past two decades, yet underscored the continuing unmet needs for FL patients. She highlighted the potential of newer treatments like Breyanzi to deliver significant, enduring outcomes in regular clinical settings.

The approval of Breyanzi in FL was announced shortly after BMS secured EC approval for another therapy combination for hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. The dual immunotherapy treatment comprises Opdivo (nivolumab) and Yervoy (ipilimumab) and is now authorized as a first-line option for adults with unresectable or advanced HCC. This approval was grounded in findings from the CheckMate-9DW trial, which demonstrated a notable and meaningful improvement in overall survival for patients treated with the combination therapy compared to those receiving lenvatinib or sorafenib, as selected by the investigator.

These developments underscore BMS's ongoing commitment to advancing cancer treatment, providing new hope for patients with challenging conditions such as follicular lymphoma and hepatocellular carcinoma. The use of innovative therapies like CAR T cell treatment and combination immunotherapy signifies a step forward in addressing unmet medical needs and improving patient outcomes in oncology. As BMS continues to pursue breakthroughs in cancer research, these approvals reflect the potential of cutting-edge therapies to transform the treatment landscape.