Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with 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), who are refractory or have relapsed within 12 months of initial therapy and are candidates for haematopoietic stem cell transplant (HSCT). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.
“Rates of relapsed or refractory large B-cell lymphoma after first-line therapy are very high and few patients are able to benefit from stem cell transplant, which has been the second-line standard of care for nearly 30 years,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb. “We look forward to working with the European Medicines Agency with the goal of establishing Breyanzi as a new second-line standard of care for people living with relapsed or refractory large B-cell lymphoma and, ultimately, bringing the curative potential of cell therapy to more patients.”
The type II variation is supported by data from the pivotal Phase 3 TRANSFORM study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus HSCT. In the study, Breyanzi significantly improved event-free survival (EFS) compared to standard of care, the study’s primary endpoint, and demonstrated clinically meaningful and statistically significant improvements in complete response rates and progression-free survival compared to standard of care. Breyanzi exhibited a well-established safety profile with very low rates of severe cytokine release syndrome (CRS) and neurologic events, and no new safety signals were observed in this second-line setting, consistent with the safety profile observed with Breyanzi in the third-line plus setting.
LBCL is an aggressive blood cancer and the most common type of non-Hodgkin lymphoma. Approximately 40% of patients will have disease that is refractory to or relapses after first-line treatment. High-dose chemotherapy followed by autologous stem cell transplant has been the mainstay of care in the second-line setting and historically has been the only potential for cure after failure of first-line treatment. While an estimated 50% of patients with primary refractory or relapsed disease are considered candidates for a stem cell transplant, only about 25% of these patients are able to receive stem cell transplant.
A supplemental Biologics License Application for Breyanzi for the treatment of relapsed or refractory LBCL after failure of first-line therapy is currently under Priority Review with the U.S. Food and Drug Administration (FDA), with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 24, 2022. A New Drug Application for Breyanzi for the second-line treatment of patients with relapsed or refractory LBCL is also under review with Japan’s Ministry of Health, Labour and Welfare.
Breyanzi, a differentiated CD-19 directed CAR T cell therapy, is currently approved in the European Union for the treatment of adult patients with relapsed or refractory (R/R) diffuse DLBCL, primary mediastinal large B-cell lymphoma PMBCL, and FL3B after two or more lines of systemic therapy. Breyanzi is not approved in any region for the second-line treatment of LBCL.
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