The European Medicines Agency (EMA) has validated a Type II variation application to expand the indication for Breyanzi, a CAR T cell therapy developed by Bristol Myers Squibb. Announced on August 19, 2024, this validation confirms that Breyanzi’s submission to the EMA is complete and allows for the beginning of scientific review. The expanded indication will enable the use of Breyanzi in adults with relapsed or refractory follicular lymphoma (FL) who have undergone two or more prior lines of systemic therapy.
Breyanzi, also known as lisocabtagene maraleucel (liso-cel), is a groundbreaking therapy that targets the CD19 molecule on cancerous B cells. In a Phase II study known as TRANSCEND FL, Breyanzi demonstrated a high overall response rate with responses that were both deep and durable. This chimeric antigen receptor (CAR) T cell therapy has already received approval in the European Union for treating various types of white blood cell cancers, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B). It is specifically approved for patients who relapse within 12 months after completing first-line chemoimmunotherapy or those who relapse or are refractory to DLBCL, PMBCL, or FL3B after two or more lines of systemic therapy.
Follicular lymphoma is the second-most common form of non-Hodgkin lymphoma (NHL), representing up to 30% of all NHL cases. Historically, FL has been considered challenging to cure due to frequent relapses following initial treatments. There is a significant need for effective therapies that can offer durable and complete responses. Bristol Myers Squibb noted that despite advances, treatment options that provide long-lasting remission remain limited.
Anne Kerber, senior vice president and head of Late Clinical Development, Hematology, Oncology, and Cell Therapy at Bristol Myers Squibb, highlighted the impact of FL and the therapy’s potential. She noted that patients with relapsed or refractory FL often experience progressively shorter responses with each subsequent line of therapy. Breyanzi represents a differentiated CAR T cell therapy that could significantly improve patient outcomes and provide more lasting remission periods.
Breyanzi’s safety profile is well-established, with numerous clinical trials confirming its manageability. This safety profile aligns with previous findings, reinforcing confidence in its use for treating follicular lymphoma. Additionally, Breyanzi recently received approval in Japan for treating relapsed or refractory FL after two or more lines of systemic therapy or after one prior line in high-risk patients. This approval marks Breyanzi as the first CAR T cell therapy to be authorized in the second-line setting.
The EMA’s validation of Breyanzi’s expanded indication represents a key milestone in providing more effective treatment options for patients with challenging forms of follicular lymphoma. This advancement underscores Bristol Myers Squibb’s commitment to improving outcomes and extending remission periods for patients facing this difficult disease.
References:
- Bristol Myers Squibb. European Medicines Agency Validates Bristol Myers Squibb’s Application for CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma. Press Release. Aug. 19, 2024.
- National Library of Medicine. A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL). ClinicalTrials.gov, July 22, 2024 (accessed Aug. 19, 2024).
- European Medicines Agency. Breyanzi. ema.europa.eu/en/medicines, July 31, 2024 (accessed Aug. 19, 2024).
