The move was anticipated given that, in April this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in relation to Yescarta for that type of lymphoma.
It is the third approved indication for a Kite cell therapy in Europe. The treatment was already authorized by the EC for adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.
The EU approval is supported by data from the pivotal, single-arm Phase 2 ZUMA-5 international study in patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent.
FL 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, head of the hematopoietic cell transplantation and cellular therapy unit at Lille University Hospital. He noted that 91% 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.”
FL is often misunderstood as easy to treat or non life-threatening, even when it has reached a significantly advanced stage, according to 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, she said. "Axicabtagene ciloleucel represents an important advance for a patient population in Europe with limited treatment options.”
Based in Santa Monica, California, Kite, which is owned by Gilead, has manufacturing operations in both North America and Europe.
The company received approval in June 2020 from the EMA for the manufacture of Yescarta from its facility near Amsterdam, in the Netherlands. That site is expected to facilitate treatment for up to 4,000 patients per year.