The recommendation for approval is for adult patients whose condition relapsed within 12 months of completing or did not respond to first-line chemoimmunotherapy
Breyanzi is intended to treat adult patients with relapsed or refractory large B-cell lymphoma. (Credit: Gabriel Caponetti from Wikimedia Commons)
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) as second-line treatment for relapsed or refractory large B-cell lymphoma (LBCL) in adult patients.
The CHMP’s recommendation is for the treatment of diffuse LBCL (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and follicular lymphoma grade 3B (FL3B). It is for adult patients whose condition relapsed within 12 months of completing or did not respond to first-line chemoimmunotherapy.
The CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain has been designed by Bristol Myers Squibb to improve the CAR T cells’ expansion and persistence.
Bristol Myers Squibb cell therapy development senior vice president Anne Kerber said: “This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant.
“We look forward to continuing to work with the European Medicines Agency with the goal of bringing our cell therapy, Breyanzi, and the potential for cure to more people.”
The positive opinion by CHMP was based on the findings of the TRANSFORM phase 3 study that assessed the CAR T cell therapy as a second-line treatment in adults with LBCL which is either relapsed or refractory.
The global, randomised, multicentre late-stage clinical trial compared the CAR T cell therapy with the current standard of care.
The final approval from the European Commission (EC) for the CAR T cell therapy is expected in about two months and will be applicable to all European Union (EU) member states and Liechtenstein, Norway, and Iceland.
In July 2022, Breyanzi was approved by the US Food and Drug Administration (FDA) as second-line treatment in adult patients with LBCL. The cell therapy is also approved in Japan for the same indication.
In Japan, Europe, Canada, and Switzerland, it is approved for relapsed or refractory LBCL following two or more lines of systemic therapy.