Breyanzi: CAR T-cell Therapy Gets Positive CHMP Opinion for R/R Large B-Cell Lymphoma Manali Kamdar, MD - Synopsis below extracted from the video transcript.
Breyanzi, a CAR T-cell therapy developed by Bristol Myers Squibb, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (R/R LBCL).
The positive opinion was based on the results of the Phase 1/2 TRANSCEND NHL 001 trial, which demonstrated the efficacy and safety of Breyanzi in treating patients with R/R LBCL. In the trial, patients received a single infusion of Breyanzi after undergoing lymphodepletion with fludarabine and cyclophosphamide. The overall response rate was 73%, with a complete response rate of 54%. The median duration of response was 16.7 months.
Breyanzi is a type of chimeric antigen receptor (CAR) T-cell therapy, which involves genetically modifying a patient's own T cells to target cancer cells. Breyanzi targets the CD19 antigen, which is expressed on the surface of B cells, including cancerous B cells.
The positive CHMP opinion is an important step in bringing Breyanzi to patients in the European Union. The next step is for the European Commission to issue a marketing authorization for Breyanzi. If approved, Breyanzi would be the third CAR T-cell therapy approved for the treatment of R/R LBCL in the European Union, after Kymriah and Yescarta.
The development of CAR T-cell therapies has revolutionized the treatment of certain types of cancer, particularly blood cancers. These therapies have shown remarkable efficacy in treating patients who have exhausted all other treatment options. However, they also carry significant risks, including cytokine release syndrome and neurotoxicity, which require close monitoring and management.
Overall, the positive CHMP opinion for Breyanzi is a promising development for patients with R/R LBCL in the European Union, and it highlights the potential of CAR T-cell therapies in the treatment of cancer.
