![]() Meanwhile other studies with axicabtagene ciloleucel are also advancing. We believe that the solid efficacy profile demonstrated by the pivotal ZUMA-1 study should support the drug’s approval this year. Ongoing analysis demonstrated that axicabtagene ciloleucel’s efficacy was stable with 44% ORR and 39% CR. Previously, top-line data announced in February from the study showed that at month 6, after axicabtagene ciloleucel treatment, 41% of the patients achieved a response, including 36% achieving a complete response (CR). The study met the primary endpoint of objective response rate, or ORR, recorded after a single infusion of axicabtagene ciloleucel, with 82%. In April, Kite Pharma presented detailed data from this study at the annual meeting of the American Association of Cancer Research (AACR). In Europe, a regulatory application is expected to be filed in the third quarter of this year. The Biologics License Application (BLA) filing was based on data from the ZUMA-1 study. for treating aggressive non-Hodgkin lymphoma (NHL) with a FDA decision expected on Nov 29. Kite Pharma’s lead drug axicabtagene ciloleucel (previously KTE-C19) is an anti-CD19 CAR-based therapy currently under priority review in the U.S. This can be done by stimulating the immune system to attack cancer cells or by introducing immune system components into the body. The basic concept of cancer immunotherapy or immuno-oncology is to utilize certain parts of the immune system to fight the disease. Kite Pharma is focused on the development of immuno-oncology treatments, which is a hot therapeutic area with huge commercial potential. ![]()
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