Bristol-Myers Squibb Company (BMY) announced on Monday that the European Medicines Agency has validated its Type II variation application to expand the indication for Breyanzi. This expansion aims to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
Breyanzi, a CAR T cell therapy, is created from a patient’s own T cells. These cells are collected and genetically reengineered to become CAR T cells, which are then administered via infusion as a one-time treatment, according to the company statement.
The application is supported by data from the Phase 2 TRANSCEND FL study, which demonstrated a high overall response rate in adults with relapsed or refractory FL treated with Breyanzi.
Furthermore, Japan's Ministry of Health, Labour and Welfare has approved a supplemental New Drug Application for Breyanzi. This approval is for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy. Breyanzi now holds the distinction of being the first CAR T therapy approved in the second-line setting globally and has achieved its third approval in Japan.
Currently, Bristol-Myers Squibb’s stock (BMY) is trading at $49.82, reflecting an increase of 0.89 percent on the New York Stock Exchange.
