CHMP Gives Kite’s Lymphoma Immunotherapy a Positive Opinion

On September 16, Kite, a Gilead Sciences company, announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Yescarta (axicabtagene ciloleucel), a treatment for lymphoma. The Chimeric Antigen Receptor (CAR) T-cell therapy’s approval is based on the results of the Phase 3 ZUMA-7 study.

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What does Yescarta treat?

Lymphoma is a cancer of the body’s anti-germ network, known as the lymphatic system. This system contains the lymph nodes, spleen, thymus gland, and bone marrow. One of the types of lymphoma is Non-Hodgkin’s lymphoma, wherein cancer forms in white blood cells and spreads tumors throughout the body. 

Typically, Non-Hodgkin lymphoma is treated with chemotherapy or radiotherapy. In certain cases, if the cancer is small enough, a biopsy might be enough for treatment. One example of this is cyclophosphamide, a chemotherapy that slows cancer’s growth by suppressing the immune system.

Yescarta, on the other hand, is a CAR T-cell therapy. The immunotherapy treats cancer with a patient’s own white blood cells, known as T-cells, after genetic modification. The edit causes the cells’ production of a protein called chimeric antigen receptor (CAR). Upon reintroduction, CAR attaches to a receptor on the surface of cancer cells and kills them. 

The ZUMA-7 Wins Over the EMA

ZUMA-7 is an ongoing Phase 3 clinical trial evaluating the safety and efficacy of a single infusion of Yescarta versus the current standard of care for second-line therapy. The study tested 359 adult patients with large B-cell lymphoma, a subtype of Non-Hodgkin lymphoma. The primary endpoint of the trial was event-free survival.

Overall, Yescarta-treated patients saw an average of 8.3 months of event-free survival compared to the standard of care’s average of 2.0 months. This data won a positive opinion from the CHMP on the immunotherapy. 

On the CHMP’s opinion, Christi Shaw, CEO of Kite, said, “Today’s positive CHMP opinion brings us a step closer to utilizing cell therapy earlier in the treatment journey, potentially transforming the standard of care for the most common and aggressive form of non-Hodgkin lymphoma.”

Going forward, the European Commission will review the CHMP’s opinion. Their final decision on granting marketing authorization for the treatment is expected in the coming months.

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Author

Max Heirich