The European Medicines Agency (EMA) has validated an application to expand the indication of Breyanzi for treating relapsed or refractory follicular lymphoma (FL) in adults who have received two or more prior systemic therapies.
Data from the Phase 2 TRANSCEND FL trial, the largest study of CAR T cell therapy in FL, supports the application. Breyanzi demonstrated a high overall response rate, with deep and durable responses. Its safety profile remains consistent with previous clinical trials.
FL, the second most common NHL, has a high relapse rate after first-line therapy. Breyanzi aims to provide treatment-free intervals with durable responses.
Previously approved in the EU for certain B-cell lymphomas, Breyanzi now seeks approval for FL patients who have relapsed within 12 months of completing first-line chemoimmunotherapy or are refractory to it. It also targets patients who have relapsed or are refractory after two or more lines of systemic therapy.
The EMA’s validation marks the initiation of the scientific review process for Breyanzi’s expanded indication in FL. Bristol Myers Squibb aims to bring this therapy to FL patients to improve outcomes and achieve long-term remission.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
