FDA clears BMS’ Breyanzi for follicular lymphoma

Bristol-Myers Squibb has chalked up another FDA approval for its CD19-directed CAR-T therapy Breyanzi, this time as a third-line or later therapy for follicular lymphoma (FL).

The accelerated approval comes a few weeks after Breyanzi (lisocabtagene maraleucel or liso-cel) became the first CAR-T to be approved for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), and ahead of another FDA decision in mantle cell lymphoma (MCL), which is due around the end of this month.

The CAR-T was first approved in 2021 as a third-line or later treatment for large B-cell lymphoma and brought in $364 million in revenues last year, double the prior year after its label was extended in 2022 to include second-line therapy. Nevertheless, at the moment it is still trailing behind the market-leading CD19 CAR-T, Gilead Sciences' Yescarta (axicabtagene ciloleucel), which had $1.5 billion in sales in 2023.

Analysts at GlobalData have suggested that, with the new indications in place, Breyanzi could close the gap with Yescarta, predicting sales of $2 billion and $2.5 billion respectively for the two CAR-Ts by 2030.

The new approval is based on the phase 2 TRANSCEND FL study, which involved adult patients with relapsed or refractory FL who had received two or more prior lines of systemic therapy. There was an overall response rate (ORR) of almost 96% among patients who received the CAR-T therapy, including 73% complete responses based on a negative bone marrow biopsy.

The one-shot therapy worked quickly, with a median time to response of just a month, and so far the median duration of response has not been able to be calculated. After 12 months, nearly 81% of responding patients were still in response, dropping only slightly to 77% at 18 months.

“In the treatment of relapsed or refractory FL, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” commented Lia Palomba, a lymphoma cell therapy specialist at Memorial Sloan Kettering Cancer Centre in the US and a TRANSCEND investigator.

“The FDA approval of liso-cel for patients with relapsed or refractory FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients with a new option that has shown remarkably high response rates and an established safety profile,” she added.

BMS views Breyanzi as the core of its cell therapy franchise and is anticipating rising demand for that, as well as BCMA-directed CAR-T Abecma (idecabtagene vicleucel) for multiple myeloma. In April, it signed a $380 million deal with contract manufacturer Cellares to shore up manufacturing capacity for the two CAR-Ts.