EMA Expands Indication for Bristol Myers Squibb Follicular Lymphoma Therapy

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The European Medicines Agency (EMA) has validated a Type II variation application that expands the indication for Breyanzi, a Bristol Myers Squibb product, to include treatment of adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy (1). The validation, which confirms the completion of the therapy’s submission to EMA and allows scientific review to begin, was announced by Bristol Myers Squibb in a press release on Aug. 19, 2024.

Breyanzi (lisocabtagene maraleucel; liso-cel) is a CD19 molecule-directed chimeric antigen receptor (CAR) T cell therapy which, in a Phase II study (TRANSCEND FL), demonstrated a high overall response rate with “deep and durable” responses (1,2). It has been approved in the European Union for use in adult patients with various forms of white blood cell cancers, such as the following:

• diffuse large B-cell lymphoma (DLBCL)
• high-grade B-cell lymphoma (HGBCL)
• primary mediastinal large B-cell lymphoma (PMBCL)
• follicular lymphoma grade 3B (FL3B).

It is approved for those patients who relapsed within 12 months of completion of—or are refractory to—first-line chemoimmunotherapy, or who may have relapsed or refractory DLBCL, PMBCL, or FL3B after two or more lines of systemic therapy (1,3).

Follicular lymphoma comprises up to 30% of all cases of non-Hodgkin lymphoma (NHL), making it the second-most common form of NHL (1). FL has typically been considered incurable, as patients are known to frequently relapse after front-line therapy, and Bristol Myers Squibb said needs remain unmet as far as options for treatment-free intervals that offer durable and complete responses.

“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 and head of Late Clinical Development, Hematology, Oncology, and Cell Therapy at 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 said Breyanzi has a “well-established and manageable” safety profile, demonstrated in numerous clinical trials, and that the safety of the therapy for treatment of follicular lymphoma is in line with those prior results (1).

Breyanzi was also recently approved in Japan based on the results of the TRANSCEND FL study, its third approval in that country, for treatment of relapsed or refractory FL after two or more lines of systemic therapy, or after one prior line in patients at high risk (1). It is the first CAR T cell therapy anywhere to be approved in the second-line setting, according to Bristol Myers Squibb.

References

1. 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.
2. 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).
3. European Medicines Agency. Breyanzi. ema.europa.eu/en/medicines, July 31, 2024 (accessed Aug. 19, 2024).