The latest explanation of the effects and side effects of giritinib

Gilitinib is a second-generation TKI. In human studies, its single-agent activity against FLT 3-itd and TKD mutations was stronger than that of the first-generation drug. In addition, in 191 patients with FLT3-mutated relapsed/refractory (R/R) acute myeloid leukemia (AML), the Phase I/II dose-escalation and dose-expansion Chrysalis trial showed that geritinib had an acceptable safety profile and an overall response rate (ORR) of 49%.

The pivotal ADMIRAL trial showed that the median overall survival of patients treated with gilritinib was significantly longer than that of patients treated with chemotherapy (9.3 months and 5.6 months respectively). The ORR of gilritinib was 67.6%, which was better than the 25.8% in the chemotherapy group, and it was approved for clinical use by the U.S. Food and Drug Administration (FDA). Common side effects of giritinib include diarrhea, elevated aspartate aminotransferase, febrile neutropenia, anemia, thrombocytopenia, sepsis, and pneumonia.

The original drug of giritinib has been launched in China, but it has not yet been included in the medical insurance. The price of each box of 40mg*42 tablets may be more than 20,000 yuan, and the price of the Hong Kong version of the original drug is about 90,000 yuan per box. The price of the European version of the original drug, 40mg*84 tablets, per box listed overseas is around RMB 210,000 (the price may fluctuate due to exchange rates), which is very expensive. Generic drugs of giritinib are currently produced and sold overseas, and their drug ingredients are basically the same as those of the original drugs sold domestically and abroad. For example, the price of 40mg*84 tablets per box produced by a Laos pharmaceutical factory is more than 4,000 yuan (the price may fluctuate due to the exchange rate).