New breakthrough in the full-cycle management of giritinib in 2026: from relapse and refractory treatment to post-transplantation maintenance, medical insurance negotiation and the depth of generic drug accessibility

GiritinibNew breakthroughs in full-cycle management in 2026: from relapse and refractory treatment to post-transplantation maintenance, medical insurance negotiations and the depth of generic drug accessibility

Giritinib fumarate tablets (XOSPATA) is a targeted therapy drug specifically used to treat patients with acute myeloid leukemia (AML) with FMS-like tyrosine kinase 3 (FLT3) mutations. AML is a malignant tumor of the blood and bone marrow that usually develops rapidly and has a short life expectancy without effective treatment. With in-depth research on the pathogenesis of AML, FLT3 mutation has been found to be one of the common driver mutations in AML patients. As a drug targeting FLT3, giritinib fumarate has achieved significant efficacy in clinical treatment.

However, in China, although the original drug of giritinib is already on the market, it is not included in medical insurance, so the treatment burden on patients is still heavy. The high price makes many patients face a choice dilemma, especially when the price gap between generic drugs and generic drugs is huge. This article will discuss the mechanism of action, clinical application, domestic and foreign market differences and future development prospects of giritinib fumarate.

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1. The treatment landscape of FLT3 mutated AML and the strategic position of giritinib

Acute myeloid leukemia (AML) is the most common leukemia subtype in adults, and its FLT3 mutant subtype has long plagued clinical practice due to its high recurrence rate and low survival rate. According to data disclosed at the ASH Conference in 2025, approximately 37% of newly diagnosed AML patients have FLT3 mutations, and the 5-year survival rate of such patients is less than 20%. As a second-generation FLT3 inhibitor, geritinib achieved a median overall survival (OS) extension of 4.6 months in the phase III ADMIRAL trial by precisely inhibiting the FLT3-ITD/TKD double mutation signaling pathway, with a complete response rate (CR) of 25%. In January 2025, China's NMPA officially granted giritinib routine approval, marking a new era of targeted therapy for the treatment of FLT3-mutated AML in China.

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2. The latest clinical research progress: breakthrough evidence from relapse and refractory treatment to full-cycle management

1. Milestone research in the field of relapse and refractory treatment

A summary analysis of the ADMIRAL and COMMODORE trials announced at the 2025 ASH conference showed that the median OS of FLT3-mutant R/R AML patients treated with geritinib was not reached after restarting treatment, but was only 10.1 months in the non-restart group. The RR-FLT3-AML220 study conducted by Japanese scholars further verified that the mitoxantrone-etoposide-cytarabine (MEC) chemotherapy followed by giritinib regimen can achieve a CR rate of 48.8% and a composite CR rate (CRc) of 87.8%, with a median OS of 32.2 months.

2. Exploration of triple solutions in new diagnostic fields

The VICEROY study showed that the "triple regimen" of giritinib combined with venetoclax and azacitidine had a CR rate of 70%-90% and a 12-month OS rate of 64%-77% in newly diagnosed FLT3-mutated AML patients who were not suitable for intensive chemotherapy. Long-term follow-up confirmed that the median RFS was 23.4 months, the 3-year OS rate was 46%, and there was no significant difference in prognosis whether transplanted or not.

3.Innovative strategies for maintenance treatment after transplantation

Post hoc analysis of the MORPHO trial showed that the 3-year RFS rate significantly increased to 58.8% when AML received transplantation combined with giritinib maintenance therapy <120 days after diagnosis. Japan's nationwide registration study confirmed that the relapse rate of cord blood transplant (CBT) patients after receiving maintenance treatment with giritinib was reduced to 27.6%, and the 3-year OS rate reached 64.4%, which was 23 percentage points higher than that of the non-maintenance group.

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3. Clinical application: Indications and dosage of giritinib fumarate

Giritinib is approved to treat adult patients with acute myeloid leukemia who have FLT3 mutations. AML is a serious blood disease, mainly manifested by the massive proliferation of cancerous white blood cells in the blood and bone marrow, resulting in a reduction in the number of normal blood cells, which in turn affects physiological activities such as oxygen delivery and immune function.

ForAML patients, the recommended dose of XOSPATA is 120 mg orally once daily. Before receiving treatment, patients need genetic testing to confirm the presence of FLT3 mutations. This drug is not currently undergoing clinical trials in children, so its safety and effectiveness in children have not been confirmed.

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4. Current status of medical insurance negotiationsand global original drug and generic drug gradientAnalysis

1. Medical insurance information and domestic prices:

As of January 2026, giritinib has not yet been included in the national medical insurance catalog. The specification is 40mg*21 tablets*2 tablets. Each box is priced at more than 20,000 yuan, and the annual treatment cost for patients may be as high as hundreds of thousands of yuan. According to the 2026 medical insurance negotiation candidate list, whether the drug can be included depends on the price reduction of pharmaceutical companies and the medical insurance fund budget. In the Hong Kong market, the price of gilitinib is as high as RMB 90,000 per box.

2. Overseas price analysis:

The price of giritinib in Europe is higher compared with the domestic market. In the European market, the price of 40mg*84 tablets of gilitinib may reach 200,000 yuan, which is a huge financial pressure for many patients. However, with the advent of generic drugs, patients' choices are gradually increasing. The Laotian version of giritinib is priced at only 2,000 yuan per box. Although it is cheap, its drug ingredients are similar to the original drug, so it may be the first choice for some patients. Clinical practice recommends strengthening blood routine and liver function monitoring during medication to prevent adverse reactions such as elevated transaminases and myalgia.

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5. Possible adverse reactions and side effects

Although giritinib has demonstrated good efficacy in clinical practice, its use is also associated with certain side effects. Based on clinical data, the most common adverse reactions include:

1. Elevated transaminase: one of the markers that affects liver function.

2. Myalgia and joint pain: manifested as general discomfort.

3. Fatigue and discomfort: common symptoms that affect patients’ quality of life.

4. Fever and edema: may be related to the immune response to the drug.

5. Rash and mucositis: common skin reactions.

6. Non-infectious diarrhea: This is a common adverse reaction of the digestive system during XOSPATA treatment.

In addition, giritinib may cause other serious adverse reactions, such as renal damage, hypotension, and dyspnea. Therefore, the patient's health needs to be closely monitored during use and managed accordingly based on specific symptoms.

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6. Indications expansion and clinical application guiding principles: a new paradigm of standardized diagnosis and treatment

China's first "Guiding Principles for the Clinical Application of Giritinib (2025 Edition)" was formulated by the CSCO Leukemia Expert Committee, clarifying the FLT3 mutation detection standards, medication regimens and MRD monitoring timing. The guideline emphasizes the core position of high-sensitivity MRD dynamic monitoring in post-transplantation maintenance treatment and standardizes the adverse reaction management path. For example, abnormal liver function requires dose adjustment, and renal function impairment requires monitoring of serum creatinine.

VII. Future Prospects: Precision Diagnosis and Treatment and Global Resource Integration

Withthe long-term follow-up results of the COMMODORE study presented at the 2025 EHA Conference, the value of geritinib in the full-cycle management of AML has been further highlighted. Future development directions include: 1) exploring combined applications with immunotherapies such as CAR-T; 2) developing oral sustained-release preparations to improve patient compliance; 3) establishing a global generic drug quality certification system.

References:

https://www.prnewswire.com/news-releases/astellas-to-present-new-data-on-xospata-gilteritinib-across-the-flt3m-aml-disease-continuum-at-ash-2025-annual-meeting-302633927.html

https://clinicaltrials.gov/study/NCT05520567

https://go.drugbank.com/drugs/DB12141

https://www.xospata.com/

https://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Gilteritinib_monograph.pdf