Bristol Myers Squibb has received application validation from the European Medicines Agency (EMA) for its Type II variation application for Breyanzi.
The pharmaceutical companies aims to extend the indication of the CAR T cell therapy — otherwise called liso-cel — to the treatment of adults with relapsed or refractory follicular lymphoma (R/R FL).
Breyanzi, if approved, would be administered to patient populations who have previously received two or more treatment lines.
Following validation from the EMA, the therapeutic will be assessed by the regulatory board for this indication.
“Follicular lymphoma impacts a significant number of people, and those with relapsed or refractory disease tend to experience shorter responses with each new line of therapy,” said Anne Kerber, senior vice president, head of Late Clinical Development, Hematology, Oncology and Cell Therapy (HOCT), Bristol Myers Squibb.
“Breyanzi represents a differentiated CAR T cell therapy, and we look forward to working with the European Medicines Agency to bring this important treatment option to patients with relapsed or refractory follicular lymphoma with the goal of improving outcomes and providing lasting remission.”
Bristol Myers Squibb’s application is fortified by data from he Phase II TRANSCEND FL study, which assessed the efficacy of CAR T cell therapy in patients with indolent non-Hodgkin lymphoma — which includes R/R FL.
In this study, the immunotherapy exhibited a high overall response rate with a manageable safety profile.
Breyanzi is currently approved in the European Union for the treatment of adult patients with:
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
- High grade B-cell lymphoma (HGBCL)
- Primary mediastinal large B-cell lymphoma (PMBCL)
- FL grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy
- Adult patients with Relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy.
