Just two months after earning another approval for its blockbuster blood cancer drug Breyanzi, Bristol Myers Squibb can add an accelerated approval to the list, this time in the third-line setting for adult patients with relapsed or refractory follicular lymphoma.
The FDA approved the single-dose, one-time CAR-T therapy for the indication based on response rate and duration of response in the TRANSCEND-FL trial — the overall response rate was 95.7% while the complete response rate was 73.4%. Bristol Myers said the responses were “rapid and durable,” with 80.9% still responding at 12 months, and 77.1% responding at 18 months.
“In the treatment of relapsed or refractory follicular lymphoma, patients often cycle through treatments with typically shorter responses with each new line of therapy,” TRANSCEND trial investigator and specialist at Memorial Sloan Kettering Cancer Center M. Lia Palomba said in a statement. “Those who have experienced early disease progression have notably poor prognosis.”
According to the FDA, the most common adverse events in the trial included cytokine release syndrome, fatigue, constipation and fever, with Bristol Myers adding that cytokine release syndrome occurred in 53% of patients. Breyanzi has a boxed warning.
Breyanzi brought in $107 million in the first quarter of 2024 and $364 million in 2023, according to Bristol Myers’ latest financial report. The FDA approved it in third-line relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma in March. The drug was already approved in the US, Japan and Europe as a second-line treatment of relapsed or refractory large B cell lymphoma, and in Japan, Europe and Canada for relapsed and refractory large B cell lymphoma in the third-line setting.
BMS is also still waiting on a response from the FDA for another approval for Breyanzi in relapsed or refractory mantle cell lymphoma, with a PDUFA date of May 31.