Bristol Myers Squibb gets positive response for advanced CAR-T therapy Breyanzi®
Breyanzi® – an advanced CAR-T cell therapy – has been given a positive recommendation by the European Medicines Agency (EMA; Amsterdam, The Netherlands) and is currently being evaluated by the European Commission.
The EMA has announced that its Committee for Medicinal Products for Human Use responded positively to Bristol Myers Squibb’s (BMS; NY, USA) application for Breyanzi (lisocabtagene maraleucel) to treat aggressive lymphomas.
Breyanzi is an advanced CAR-T cell therapy for *r/rlbcl and – overall – it is well tolerated. However, it can cause serious side effects such as cytokine release syndrome (CRS).
Approval of CD-19 directed CAR-T cell therapy is recommended for use in adults with diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B in the third-line setting.
In around 50–60% of cases, patients will achieve a long-term response with standard-of-care immune-chemotherapy. But, for patients who do not respond to standard therapy or whose cancer has reoccurred, treatment outcomes remain complex.
The Committee for Medicinal Products for Human Use recommendation was based on results from the Phase I single-arm TRANSCEND NHL 001 trial and data from the mid-stage TRANSCEND WORLD study. Both studies assessed patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade, including those with a range of histologies and high-risk disease.
BMS stated that during these studies, Breyanzi generated an overall response rate of 73% among 192 individuals who received treatment in TRANSCEND NHL 001, including 54% of individuals with complete responses.
Anne Kerber, Senior Vice President at BMS, stated, “this positive Committee for Medicinal Products for Human Use opinion is an important milestone that recognizes Breyanzi as a differentiated cell therapy with the potential to address unmet needs for patients in the European Union with aggressive lymphomas who have limited treatment options. We look forward to the European Commission’s decision as we continue to accelerate our research in cell therapy to develop new treatment options for patients living with difficult to treat blood cancers.”
Advice from the Committee for Medicinal Products for Human Use advice will be evaluated by the European Commission. If Breyanzi is approved, it will be made available to individuals in European Member states, Iceland, Norway and Liechtenstein.