On August 20th, Bristol Myers Squibb announced that the European Medicines Agency (EMA) has completed the validation of its new indication application for CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso cel) and will begin reviewing Breyanzi's efficacy in treating adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more lines of systemic treatment. The press release states that Breyanzi has been approved in Japan for the treatment of high-risk FL patients, making it the first CAR-T therapy approved for such high-risk FL patients.
FL is the second most common slow growing form of non Hodgkin's lymphoma (NHL), accounting for 20 to 30% of all NHL cases. Most FL patients are diagnosed at an age over 50 years old. During the development of FL, white blood cells accumulate in lymph nodes or organs of the human body to form lumps. The characteristic of FL is the alternating occurrence of recurrence and remission, making it more difficult to treat the disease after recurrence or progression.
Breyanzi is an autologous CAR-T cell therapy targeting CD19 antigen, with a clear composition and 4-1BB co stimulatory domain. It was approved by the FDA in February 2021 for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) who have received two or more systemic treatments.
This application is mainly based on the results of the TRANSCEND FL test. This is an open label, global, multicenter phase 2 single arm trial evaluating the efficacy of Breyanzi as a second-line and third line or above therapy in patients with relapsed or refractory indolent non Hodgkin lymphoma (including FL).
