The European Commission (EC) has approved biotechnology company Kite’s CAR T-cell therapy Yescarta for patients with follicular lymphoma (FL).
Specifically the approval is for adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
The approval was based on data from the ongoing single-arm Phase II ZUME-5 study which evaluated 122 patients with relapsed or refractory follicular lymphoma (FL), who received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. For 75 patients, who had received three or more lines of prior therapy, the overall response rate (ORR) was 91% with a complete response (CR) rate of 77% at a two-year analysis.
Follicular lymphoma is a form of non-Hodgkin lymphoma in which tumours grow slowly but can become more aggressive over time. It is the second most common type of lymphoma and accounts for around 22% of all lymphoma cases worldwide1.
“Follicular lymphoma that has relapsed multiple times is a difficult-to-treat disease with an especially poor prognosis as only 20% of patients are still alive at five years after their second relapse,” said Ibrahim Yakoub-Agha, MD, PhD, Head of the Hematopoietic Cell Transplantation and Cellular Therapy Unit, Lille University Hospital. “Ninety-one percent of patients in the ZUMA-5 study responded to axicabtagene ciloleucel after three or more prior lines of therapy, and more than half of these were still in response two years later. This sign of durable remission is critical for patients who need options that can deliver long-term benefit.”
“Follicular lymphoma is often misunderstood as easy to treat or non life-threatening, even when it has reached a significantly advanced stage,” said Nicola Mendelsohn, Founder and Chair of the Follicular Lymphoma Foundation (FLF). “For patients with later-line relapsed or refractory disease, it is often very aggressive. Axicabtagene ciloleucel represents an important advance for a patient population in Europe with limited treatment options.”
“Patients with advanced relapsed or refractory follicular lymphoma have a high need for new treatment options,” said Christi Shaw, CEO, Kite. “This is the third approved indication for a Kite cell therapy in Europe, and we are pleased to enable more patients with different lymphomas greater access to this treatment innovation.”