The receptor tyrosine kinase FMs-like tyrosine kinase 3 (FLT3) is involved in regulating the survival, proliferation, and differentiation of hematopoietic stem/progenitor cells and is expressed in cancer cells. FL-T3 mutations cause ligand-independent cell survival, proliferation, and resistance to apoptosis. FLT3 inhibitors interact with the ATP- binding site of the intracellular tyrosine kinase domain and competitively inhibit ATP binding, thereby preventing autophosphorylation and activation of downstream signaling. FLT3 inhibitors are used in the treatment of chronic myeloid leukemia, precursor cell lymphoblastic leukemia-lymphoma, liver cancer, renal cell carcinoma, thyroid cancer, and others. Sanofi, Bayer, Novartis, Bristol-Myers Squibb, Takeda Oncology, and Exelixis are some of the major players in the market for FLT3 inhibitors. Additionally, there are several drug molecules in the clinical trial phases of pharmaceutical companies for other indications.
Key Market Developments:
- In Feb 2023, FDA granted seven years of orphan drug exclusive approval for Pacritinib for the treatment of myelofibrosis in the USA to CTI BioPharma.
- In Apr 2023, PDUFA action date was extended to 24/07/2023 for NDA for FLT3-ITD positive acute myeloid leukemia by US FDA for Daiichi Sankyo Company’s Quizartinib.
Approved Drug Molecules and Brand Names for FLT3 Inhibitors:
- Sorafenib (Nexavar)
- Sutent (Sunitinib)
- Cabometyx (Cabozantinib tablet)
- Nintedanib
- Iclusig (Ponatinib)
- Cometriq (Cabozantinib capsule)
- Xospata (Gilteritinib)
- Vonjo (Pacritinib)
- Vanflyta (Quizartinib)
Drugs under the Pipeline for FLT3 Inhibitors:
- Dovitinib (TKI258)
- Rydapt (Midostaurin)
- Famitinib (SHR 1020)
- Alunbrig (Brigatinib)
- Inrebic (Fedratinib)
- Turalio (Pexidartinib)
- Crenolanib (ARO-002)
- Linifanib (ABT-869)
- Lestaurtinib (CEP-701)
- Mivavotinib (CB-659)
- Gavreto (Pralsetinib)
- Qinlock (Ripretinib)
- Ruserontinib (SKLB-1028)
- ENMD-2076
- Max-40279
- Tandutinib (MLN518)
- Zotiraciclib (TG02)
- Ningetinib (CT053PTSA)
- Emavusertib (CA-4948)
- KC1036
- MRX2843
- Amuvatinib (MP470)
- Clifutinib (HEC73543)
- Rebastinib (DCC-2036)
- XY0206
- Flonoltinib
Clinical Activity and Developments of FLT3 Inhibitors:
There are more than 60 products, including about 10 approved drug products and other drugs in the clinical trial phases.
- In Feb 2023, Bristol-Myers Squibb, in collaboration with Exelixis, initiated a phase-II CANOPY trial for prostate cancer in the USA for Cabozantinib (Cometriq).
- In March 2023, Incyte Biosciences International and University Hospital Frankfurt completed a phase-II trial in precursor cell lymphoblastic leukemia-lymphoma in Germany for Ponatinib.
|
Molecule Name |
Number of Studies |
|
Dovitinib (TKI258) |
60 |
|
Rydapt (Midostaurin) |
58 |
|
famitinib (SHR 1020) |
52 |
|
Alunbrig (Brigatinib) |
36 |
|
Inrebic (Fedratinib) |
32 |
|
Turalio (Pexidartinib) |
32 |
|
Crenolanib (ARO-002) |
21 |
|
Linifanib (ABT-869) |
20 |
|
Lestaurtinib (CEP-701) |
15 |
|
Mivavotinib (CB-659) |
15 |
|
Gavreto (Pralsetinib) |
12 |
|
Qinlock (Ripretinib) |
12 |
|
Ruserontinib (SKLB-1028) |
9 |
|
ENMD-2076 |
8 |
|
Max-40279 |
8 |
|
Tandutinib (MLN518) |
8 |
|
Zotiraciclib (TG02) |
8 |
|
Ningetinib (CT053PTSA) |
7 |
|
Emavusertib (CA-4948) |
6 |
|
KC1036 |
4 |
|
MRX2843 |
4 |
|
Amuvatinib (MP470) |
4 |
|
Clifutinib (HEC73543) |
4 |
|
Rebastinib (DCC-2036) |
4 |
|
XY0206 |
3 |
|
Flonoltinib |
3 |
Target Indication Analysis of FLT3 Inhibitors
Ponatinib is indicated for chronic myeloid leukemia and precursor cell lymphoblastic leukemia-lymphoma and it is in phase-II for acute myeloid leukemia, biliary cancer, gastrointestinal stromal tumors, lung cancer, squamous cell cancer, and thyroid cancer. Cabozantinib and Sorafenib are marketed for liver cancer, renal cell carcinoma, and thyroid cancer. Cabozantinib is also in phase-III for non-small cell lung cancer and prostate cancer. Sunitinib is used in the treatment of gastrointestinal stromal tumors, pancreatic cancer, and renal cell carcinoma and is in phase-II for alveolar soft part carcinoma, bladder cancer, neuroendocrine tumors, oesophageal cancer, phaeochromocytoma, prostate cancer, and uveal melanoma.
Regional Analysis of FLT3 Inhibitors
FLT3 Inhibitors Market
Cancer is one of the leading causes of mortality globally. According to the World Health Organization, China had the highest number of new cases of leukemia (85,404), followed by the USA (61,252), and India (48,419) in 2020. In the case of liver cancer, China had 4,10,038 new cases, followed by Japan (45,663) and the USA (42,284) in 2020. For thyroid cancer, China had the highest number of new cases (2,21,093), followed by the USA (52,912). Bayer’s Nexavar (Sorafenib) had a total sale of US$ 292 million in the year 2022, which was a decline from the year 2021 total sales of US$ 476 million. Exelixis’s Cabometyx (Cabozantinib) had a total sale of US$ 1,376 in the USA in 2022, which was an increase from the sales of US$ 1,054 million in 2021 and the company will see all of the patent expiration for Cabometyx by 2033.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Sorafenib (Nexavar), Sutent (Sunitinib), Cabometyx (Cabozantinib tablet), Nintedanib, and Iclusig (Ponatinib) are some of the approved FLT3 inhibitors in the market.
Sanofi, Bayer, Novartis, Bristol-Myers Squibb, Takeda Oncology, and Exelixis are some of the major players in the market for FLT3 inhibitors.
Major indications for FLT3 inhibitors are chronic myeloid leukemia, metastatic malignant gastrointestinal stromal tumor, precursor cell lymphoblastic leukemia-lymphoma, liver cancer, renal cell carcinoma, and thyroid cancer.
There are more than 30 drug molecules in clinical development for FLT3 inhibitors.
- Novartis
- Exelixis
- Bayer
- Jiangsu Hengrui Pharma
- Astellas Pharma
- Takeda Pharmaceuticals
- BMS
- AbbVie
- Blueprint Medicines
- Reddy's Laboratories
- Otsuka Pharmaceutical
- Roche
- Amgen