NEW YORK – The European Medicines Agency (EMA) on Monday validated Bristol Myers Squibb's application to expand the indication for its autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to previously treated patients with relapsed or refractory large B-cell lymphomas.
BMS hopes to expand the indication to several types of lymphomas, including diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after first-line therapy for patients who are candidates for hematopoietic stem cell transplant.
In its application, BMS submitted data from the Phase III TRANSFORM study of Breyanzi as a second-line treatment for patients with relapsed or refractory large B-cell lymphoma. The trial compared Breyanzi to the standard-of-care treatment of salvage chemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant.
Researchers in December reported that 86 percent of 184 patients in this trial responded to Breyanzi with more than half (66 percent) achieving a complete response. In the standard-of-care arm, less than half of patients responded. Median progression-free survival was longer in the Breyanzi arm compared to the chemo arm, 14.8 months versus 5.7 months, respectively.
In April, Breyanzi was approved in Europe for relapsed or refractory large B-cell lymphoma patients after two or more lines of systemic therapy. The US Food and Drug Administration is also reviewing a supplemental biologics license application to expand Breyanzi's indication in the US to second-line large B-cell lymphoma. The FDA's decision is expected this week.
The FDA approved competitor Gilead Sciences' CAR T-cell therapy Yescarta (axicabtagene ciloleucel) as a second-line treatment for large B-cell lymphoma in April.