The European Medicines Agency (EMA) has validated Bristol Myers Squibb's Type II variation application to expand the indication for Breyanzi (lisocabtagene maraleucel) to include the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.

The application is supported by data from the Phase II TRANSCEND FL study, which showed Breyanzi demonstrated a high overall response rate with deep and durable responses in patients with relapsed or refractory follicular lymphoma.

Analyst QuickTake : Breyanzi is already approved in the European Union for certain types of large B-cell lymphomas. The EMA's validation confirms the submission is complete and allows the scientific review to begin under the centralized review procedure. In the US, Breyanzi received FDA approval in May 2024 for treating relapsed or hard-to-treat mantle cell lymphoma (MCL) and also got approvals for other conditions like follicular lymphoma , chronic lymphocytic leukemia, and small lymphocytic lymphoma earlier in the year. These approvals show that BMS is working to expand its use for different types of blood cancers, and the consistent regulatory approvals build confidence in the drug's effectiveness and safety.